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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