Job Description

​​Role and Responsibilities​ 

• Providing support to other activities undertaken by the project team on behalf of the client and the company

• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): 

  • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines 

  • Performing ICSR follow up 

  • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) 

  • Reconciliation (clinical, partners) 

  • Personal data protection 

  • Product Quality Complaint handling and interaction with Quality Assurance 

  • Medical Information interaction 

  • MedDRA and WHO coding 

  • Database Outputs and Reports (including data for monthly reporting to clients) 

  • Workflow & resource management 

• Mentoring and training of new and more junior employees within the department 

• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients 

• More senior colleague may perform tasks assigned as per SOP to more junior position 

• Performing activities in the scope of ICSR management unit within agreed extent and timeframe 

• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager 

Qualifications

Requirements: 

• Advanced English and German skills, both verbal and written, at least B2 
• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required. 
• Demonstrated experience with Case Processing
• Excellent communication (written and verbal) skills 
• Organization skills, including attention to details and multitasking 
• Delegation skills 
• Planning and time management 
• Technical skills 
• Team working 

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Job Description

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study 

Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period. 

Trains investigational site staff as necessary 

When applicable, supports preparation of regulatory and / or EC submissions 

Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance. 

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training & experience 

Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease 

Full working proficiency in English and French

Ability to plan, multitask and work in a dynamic team environment 

Communication, collaboration, and problem-solving skills 

Ability to travel nationally 

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Job Description

Provides leadership to the global medical function including medical monitoring. Contributes to the ongoing development of the Department and contributes to the business plan at both the tactical and strategic levels. Directly and through subordinate staff, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard Operating Procedures (SOPs). Additionally, this position involves cross-functional communications, strategic planning, and participation in clients’ strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors.

The Senior Medical Director will assist the Head of Medical Affairs in educating, mentoring and developing Ergomed physicians to ensure their competence and confidence in developing their skills to become subject matter experts in medical monitoring. The role requires active monitoring of costs and project deliverables and interaction with the project managers, project directors and the Head of Medical Affairs. Additionally, the role must include the review and implementation of efficiency strategies whilst maintaining the highest quality of work.

Interact with executive leadership, customers, business development, and project teams to drive the medical strategy globally.

CORE RESPONSIBILITIES

• Provides all levels of medical monitoring activities including patient safety surveillance and integrity
• Included in multi-cross-functional support to the project team in conducting clinical trials
• Could act as the main point of contact with the sponsor as a medical representative
• Coordination and delivery of trainings, supervision, and oversight of Medical Monitors
• Main point of contact and escalation for Medical Monitors
• Participation in the development and revision of Medical Monitoring SOPs
• Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisors, Medical Monitors and Study Physicians on projects
• Interacts with other departments to ensure the required quality of service is provided to a sponsor
• Providing project status reports and metrics to the VP of Global Medical Affairs during regular group meetings, in order to optimize performance (with particular reference to the amount of data, timelines, identifying issues and resolution involved)
• Keeping up to date with current and scientific knowledge in their area of expertise in order to provide high efficiency
• Business development support, proposal budget approval, out of scope approval
• Overseeing and managing a group of medical monitors/SP/medical directors
• Responsible for personnel training to meet job description requirements; responsible for personnel career development in the function

Qualifications

• Medical Doctor degree.
• Additional board certification and/or medical specialty preferred
• Active medical licenses are preferable but not mandatory.
• Extensive experience in clinical research in medical monitoring
• Strong team management background at the global level
• Expertise and extensive clinical research experience
• Experience in corporate leadership involvement and strategic contribution
• Business development experience, including review of proposals, budgets, and bid defense meeting participation required
• Proven, efficient medical communication
• Highly organized, with strong interpersonal, presentational, and documentation skills
• Proven efficiency in timely delivery
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
• In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
• Good decision-making and problem resolution based on all relevant information.
• Strategic thinking, recognizing key issues and providing practical solutions
• Ability to work effectively in an environment characterized by tight timelines and changing priorities.
• Excellent Leadership skills
• Strong coaching and mentoring skills; ability to develop and manage staff performance
• Eagerness to engage in new business contacts and grow Ergomed’s business/client base

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Job Description

We are currently seeking several motivated and enthusiastic students to join our team for one month as a full-time Admin role.

In this role, you will be assisting our Learning and Development team with various administrative tasks in our Learning Management system. Full training and support will be provided.

Estimated time for the job: from 15/05/2024 until 15/06/2024

Qualifications

Qualifications: 

• Excellent communication and teamwork skills 
• Ability to manage time effectively and meet deadlines
• Solid understanding of software and computer skills
• Experience in an administrative job is a plus

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Job Description

We are currently seeking several motivated and enthusiastic students to join our team for one month as a full-time Admin role.

In this role, you will be assisting our Learning and Development team with various administrative tasks in our Learning Management system. Full training and support will be provided.

Estimated time for the job: from 15/05/2024 until 15/06/2024

Qualifications

Qualifications: 

• Excellent communication and teamwork skills 
• Ability to manage time effectively and meet deadlines
• Solid understanding of software and computer skills
• Experience in an administrative job is a plus

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Job Description

At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.  

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. 

Responsibilities include:  

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. 

• Reconciliation activities for all types of received reports 

• Workflow management activities

Qualifications

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing    
• Must have previous experience in Data Entry or QC
• Demonstrated full start to finish case processing experience 
• ARGUS/Aris G experience preferred  
• Time and issue management, delegation, organization and multitasking skills with good attention to detail   
• Strong interpersonal and communication skills   
• Must be able to work hybrid in Pune office
• Advanced English skills, both verbal and written, at least C1  

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Job Description

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study

Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period.

Trains investigational site staff as necessary

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Demonstrated experience as a Site Coordinator or similar, working on oncology trials
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

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Job Description

The Specialist, Pharmacovigilance and Regulatory will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for pharmacovigilance and regulatory activities.

The Specialist will also act as local contact person for Pharmacovigilance for the designated country.

Job Responsibilities

• Ensure the effective and rapid coordination and management of project deliverables to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Provide Clients expertise and guidance at national level.
• Set-up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned  projects
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Manage LCPs training and assess key performance indicators
• Act as main point of contact with the clients for Regulatory and PV Network activities
• Managing project budget including vendor costs
• Act as primary contact person for local regulatory authority / Pharmacovigilance expert in assigned countries
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Review and linguistic input on local Product Information and Mock-ups 
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• Pharmacovigilance training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

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Job Description

The Project Director (PD) provides oversight and serves as an escalation point for designated projects. They are accountable for the mentoring and supervision of assigned Project Managers while also developing successful relationships with customers and clients. The PD is also accountable for maintaining relationships with assigned clients to drive increased volume of business. 

Duties and responsibilities of PD include: 

• Providing coaching/mentoring to Project Managers and contributing to departmental training initiatives 
• Serving as a liaison with Business Development;  providing expert project management and clinical input into new business budget development and Bid Defense meetings 
• Acts as key client escalation contact for designated projects and develop successful working relationships with client to drive increased volume of business 
• Actively identifying opportunities for process improvement and communicating with project teams 
• Provide regular feedback to senior management on project status, client satisfaction and staff issues 
• Supporting performance appraisal process and staff recruitment/retention 
• Supporting development and updating Ergomed Standard Operating Procedures (SOPs) 
• Contributes in qualifying and selection of company vendors 

Qualifications

• Demonstrated experience as a Project Director within the CRO industry  
• Experience working on a variety of therapeutic areas, especially complex disease areas. Preference will be given to those with a deep knowledge of Oncology or Rare Disease studies.  
• Strong previous Pharmacovigilance/Drug Safety experience is required
• Some line management experience is preferred. 
• Experience working with multiple clients and customers; maintaining high level client interactions, including Bid Defenses. 
• Strong written and verbal communication skills 

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Job Description

Provides leadership to the global medical function including medical monitoring. Contributes to the ongoing development of the Department and contributes to the business plan at both the tactical and strategic levels. Directly and through subordinate staff, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard Operating Procedures (SOPs). Additionally, this position involves cross-functional communications, strategic planning, and participation in clients’ strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors.

The Senior Medical Director will assist the Head of Medical Affairs in educating, mentoring and developing Ergomed physicians to ensure their competence and confidence in developing their skills to become subject matter experts in medical monitoring. The role requires active monitoring of costs and project deliverables and interaction with the project managers, project directors and the Head of Medical Affairs. Additionally, the role must include the review and implementation of efficiency strategies whilst maintaining the highest quality of work.

Interact with executive leadership, customers, business development, and project teams to drive the medical strategy globally.

CORE RESPONSIBILITIES

• Provides all levels of medical monitoring activities including patient safety surveillance and integrity
• Included in multi-cross-functional support to the project team in conducting clinical trials
• Could act as the main point of contact with the sponsor as a medical representative
• Coordination and delivery of trainings, supervision, and oversight of Medical Monitors
• Main point of contact and escalation for Medical Monitors
• Participation in the development and revision of Medical Monitoring SOPs
• Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisors, Medical Monitors and Study Physicians on projects
• Interacts with other departments to ensure the required quality of service is provided to a sponsor
• Providing project status reports and metrics to the VP of Global Medical Affairs during regular group meetings, in order to optimize performance (with particular reference to the amount of data, timelines, identifying issues and resolution involved)
• Keeping up to date with current and scientific knowledge in their area of expertise in order to provide high efficiency
• Business development support, proposal budget approval, out of scope approval
• Overseeing and managing a group of medical monitors/SP/medical directors
• Responsible for personnel training to meet job description requirements; responsible for personnel career development in the function

Qualifications

• Medical Doctor degree.
• Additional board certification and/or medical specialty preferred
• Active medical licenses are preferable but not mandatory.
• Extensive experience in clinical research in medical monitoring
• Strong team management background at the global level
• Expertise and extensive clinical research experience
• Experience in corporate leadership involvement and strategic contribution
• Business development experience, including review of proposals, budgets, and bid defense meeting participation required
• Proven, efficient medical communication
• Highly organized, with strong interpersonal, presentational, and documentation skills
• Proven efficiency in timely delivery
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
• In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
• Good decision-making and problem resolution based on all relevant information.
• Strategic thinking, recognizing key issues and providing practical solutions
• Ability to work effectively in an environment characterized by tight timelines and changing priorities.
• Excellent Leadership skills
• Strong coaching and mentoring skills; ability to develop and manage staff performance
• Eagerness to engage in new business contacts and grow Ergomed’s business/client base

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Job Description

The Specialist, Pharmacovigilance and Regulatory will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for pharmacovigilance and regulatory activities.

The Specialist will also act as local contact person for Pharmacovigilance for the designated country.

Job Responsibilities

• Ensure the effective and rapid coordination and management of project deliverables to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Provide Clients expertise and guidance at national level.
• Set-up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned  projects
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Manage LCPs training and assess key performance indicators
• Act as main point of contact with the clients for Regulatory and PV Network activities
• Managing project budget including vendor costs
• Act as primary contact person for local regulatory authority / Pharmacovigilance expert in assigned countries
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Review and linguistic input on local Product Information and Mock-ups 
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• Pharmacovigilance training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

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Job Description

Responsibilities include:

• Strategically support and lead the development of proposals, including support strategy development and leading TCs
• Ensure proposal input obtained from a variety of stakeholders, typically involving contributions from sales, marketing, operational teams, finance, legal and top management
• QC and sense check of stakeholder feedback;
• Ensure high quality client-focused proposals, budgets and client grids are delivered for new business opportunities;
• Attend department meetings including global RFP Triage, P&C internal meetings, and other adhoc calls;
• Support and Participate at Proposals training which includes the onboarding of new staff as well as ongoing training of existing staff as well as personnel outside the P&C team;
• Support in activities related to coordination, development, negotiation and execution of client contracts and change orders for key accounts and key opportunities;
• Support the development of Standardized procedures on a departmental level, and support in streamlining processes on proposal preparation and efficient turnaround timelines
• Support the development of junior staff by organizing  lessons learned and continued education programs to optimize team performance and growth
• Support process improvement initiatives that result in the development of costs and proposals of the highest accuracy and effectiveness;
• Ensure Senior Management are appropriately involved in QC and contribution to Key Opportunities and their strategies are effectively communicated to the client;
• Ensure continuous departmental process improvements and participate in special projects periodically assigned, in addition to day-to-day duties;

Qualifications

Demonstrated Proposals experience with Pharmacovigilance (Safety Services) or PV Providers with at least 3 years experience in the industry

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Job Description

Responsibilities include:

• Strategically support and lead the development of proposals, including support strategy development and leading TCs
• Ensure proposal input obtained from a variety of stakeholders, typically involving contributions from sales, marketing, operational teams, finance, legal and top management
• QC and sense check of stakeholder feedback;
• Ensure high quality client-focused proposals, budgets and client grids are delivered for new business opportunities;
• Attend department meetings including global RFP Triage, P&C internal meetings, and other adhoc calls;
• Support and Participate at Proposals training which includes the onboarding of new staff as well as ongoing training of existing staff as well as personnel outside the P&C team;
• Support in activities related to coordination, development, negotiation and execution of client contracts and change orders for key accounts and key opportunities;
• Support the development of Standardized procedures on a departmental level, and support in streamlining processes on proposal preparation and efficient turnaround timelines
• Support the development of junior staff by organizing  lessons learned and continued education programs to optimize team performance and growth
• Support process improvement initiatives that result in the development of costs and proposals of the highest accuracy and effectiveness;
• Ensure Senior Management are appropriately involved in QC and contribution to Key Opportunities and their strategies are effectively communicated to the client;
• Ensure continuous departmental process improvements and participate in special projects periodically assigned, in addition to day-to-day duties;

Qualifications

Demonstrated Proposals experience with Pharmacovigilance (Safety Services) or PV Providers with at least 3 years experience in the industry

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Job Description

The PrimeVigilance Medical Writer II position offers a unique opportunity to further develop your career in the field of drug safety medical writing

Key Responsibilities

• Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports- PSURs/PBRERs, PADERs, DSURs, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
• Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
• Support in all pharmacovigilance operations associated with medical writing

Qualifications

• Bachelor’s degree in healthcare or life sciences or other related disciplines.  Master’s or Doctoral degree preferred.
• Previous experience in Pharmacovigilance and aggregate report writing in industry 
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Must be a strong team player
• Fluency in English, an additional language is a benefit

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Job Description

POSITION SUMMARY

The (Junior/Senior) Client Quality Assistant supports the Client Quality Management team with administrative tasks, including but not limited to tracking, data and document preparation/review and access/training management.

Role and Responsibilities

The Junior/Senior Client Quality Assistant will be responsible for all administrative activities associated with the maintenance and management of data for reports, documentation, and systems relevant to the Client Quality Management Department.

Key responsibilities include (but are not limited to):

• Accurately creating and updating training courses and training assignments in the Learning Management System in a timely manner
• Preparation of training reports, training completion monitoring and support with periodic training assignment reviews
• Reviewing and approving Access Requests to PrimeVigilance’s controlled systems
• Periodic CV/JD review
• Assistance with preparation and compilation of data for regular reports
• Following up with relevant employees/departments to obtain missing data and responses
• Assistance with Quality Event/CAPA timelines monitoring and tracking all actions through to completion
• Preparation of PrimeVigilance procedures and procedure lists for provision to clients
• Assistance with preparation of documents for audit/inspection requests

Specified Additional Responsibilities

Other administrative support as required.

The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities.

Qualifications

• High school or university graduate
• Advanced English (both spoken and written)
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Experience in an administrative position involving management and creation of reports
• Desirable experience in data gathering
• Strong communication skills, attention to detail and problem-solving abilities
• Ability to work well in a team

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Job Description

• Works closely with the operations team to determine the scope for complex work orders and/or change orders and prepares the applicable budget.
• Drafts complex work orders and change orders with the information received from operations and/or commercial team.
• Acts as a client contact on various mid to large-sized opportunities.
• May independently manage a specific client account for the department.
• Manages contracts ensuring compliance with company policies and may lead the communication with Legal, Finance, Operations and Sales for the resolution of contract issues.
• Ensure all contractual documents and budgets undergo quality check and review.
• Liaise with Project Managers, Finance and Project Analyst to investigate budget variances. Initiate and/or review proposed contract modifications and negotiate or refer to other internal departments for review as appropriate.
• Provide regular updates to the Director of Contracts on the current status of all contract negotiations.
• Builds renewal budgets to extend the term of existing contracts.
• Maintains Salesforce records on the status of all assigned contracts.
• Ensures all fully executed contracts are distributed to the relevant parties.
• Uploads all contracts and corresponding budget files to the contracts SharePoint using the agreed folder structure and file naming convention.
• Independent oversight of the contracts mailbox to cover for vacation periods.
• Leads change within the department with oversight e.g. drafting a new process guide and providing solutions to problems raised.
• May act as a mentor/job coach to Contracts Associates. 
• Works independently and under time pressure to meet tight deadlines.
• Must be able to manage workload and prioritise activities to ensure timely completion of assignments.

Qualifications

• Ideally a bachelor’s degree in Life Sciences, Business Management, Finance or similar.
• A minimum of 2-4 years of work experience in a similar industry.
• Strong initiative to learn.
• Strong English written and oral communication skills.
• Significant experience of using Microsoft Word and Excel to an intermediate level.
• Proven ability to work well under pressure, managing multiple projects simultaneously to meet deadlines.
• Ability to build and manage professional relationships and communicate with senior leaders.
• Salesforce experience is desirable but not essential.

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Job Description

• Acting as the primary contact point for project-related matters 

• Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations. 

• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance. 

• Project activities planning, including deadlines and interim milestones 

• Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing. 

Qualifications

• Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs, writing, or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs 

• PV Project Management experience from ideally a service provide / CRO 

• Health Care Professional or Life Science Graduate 

• Be comfortable with communicating at senior levels within pharmaceutical organizations 

• Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving. 

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Job Description

The Specialist, Pharmacovigilance and Regulatory will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for pharmacovigilance and regulatory activities.

The Specialist will also act as local contact person for Pharmacovigilance for the designated country.

Job Responsibilities

• Ensure the effective and rapid coordination and management of project deliverables to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Provide Clients expertise and guidance at national level.
• Set-up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned  projects
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Manage LCPs training and assess key performance indicators
• Act as main point of contact with the clients for Regulatory and PV Network activities
• Managing project budget including vendor costs
• Act as primary contact person for local regulatory authority / Pharmacovigilance expert in assigned countries
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Review and linguistic input on local Product Information and Mock-ups 
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• Pharmacovigilance training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

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Job Description

POSITION SUMMARY

The (Junior/Senior) Client Quality Assistant supports the Client Quality Management team with administrative tasks, including but not limited to tracking, data and document preparation/review and access/training management.

Role and Responsibilities

The Junior/Senior Client Quality Assistant will be responsible for all administrative activities associated with the maintenance and management of data for reports, documentation, and systems relevant to the Client Quality Management Department.

Key responsibilities include (but are not limited to):

• Accurately creating and updating training courses and training assignments in the Learning Management System in a timely manner
• Preparation of training reports, training completion monitoring and support with periodic training assignment reviews
• Reviewing and approving Access Requests to PrimeVigilance’s controlled systems
• Periodic CV/JD review
• Assistance with preparation and compilation of data for regular reports
• Following up with relevant employees/departments to obtain missing data and responses
• Assistance with Quality Event/CAPA timelines monitoring and tracking all actions through to completion
• Preparation of PrimeVigilance procedures and procedure lists for provision to clients
• Assistance with preparation of documents for audit/inspection requests

Specified Additional Responsibilities

Other administrative support as required.

The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities.

Qualifications

• High school or university graduate
• Advanced English (both spoken and written)
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Experience in an administrative position involving management and creation of reports
• Desirable experience in data gathering
• Strong communication skills, attention to detail and problem-solving abilities
• Ability to work well in a team

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Job Description

POSITION SUMMARY

The (Junior/Senior) Client Quality Assistant supports the Client Quality Management team with administrative tasks, including but not limited to tracking, data and document preparation/review and access/training management.

Role and Responsibilities

The Junior/Senior Client Quality Assistant will be responsible for all administrative activities associated with the maintenance and management of data for reports, documentation, and systems relevant to the Client Quality Management Department.

Key responsibilities include (but are not limited to):

• Accurately creating and updating training courses and training assignments in the Learning Management System in a timely manner
• Preparation of training reports, training completion monitoring and support with periodic training assignment reviews
• Reviewing and approving Access Requests to PrimeVigilance’s controlled systems
• Periodic CV/JD review
• Assistance with preparation and compilation of data for regular reports
• Following up with relevant employees/departments to obtain missing data and responses
• Assistance with Quality Event/CAPA timelines monitoring and tracking all actions through to completion
• Preparation of PrimeVigilance procedures and procedure lists for provision to clients
• Assistance with preparation of documents for audit/inspection requests

Specified Additional Responsibilities

Other administrative support as required.

The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities.

Qualifications

• High school or university graduate
• Advanced English (both spoken and written)
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Experience in an administrative position involving management and creation of reports
• Desirable experience in data gathering
• Strong communication skills, attention to detail and problem-solving abilities
• Ability to work well in a team

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