Pharmacovigilance (PV) Associate/Senior Associate
Recruiter in Herent
1. Good understanding of the Adverse Drug Event Reporting regulations (EU and Worldwide).
2. Contribute to the development of Periodic Safety Update Reports (PSUR) as per global requirements (data extraction from the regulatory, PV and sales databases and preparation of PSUR using templates, compilation of final PSURs)
3. Ensure regulatory compliance with timelines for regulatory report submission.
4. Understand data entry conventions and expertise of query and reporting functions in the global Pharmacovigilance database – PV Works
5. Enter PV cases from countries without access to the Global PV database in global PV database with accuracy and liaise with cases owner for additional information as necessary
6. Manage case submission to third parties
7. Participate in development of procedures related to new processes as required
8. Run routine PV product reports and prepare data for further analysis by other member of the Pharmacovigilance Team and to answer ad hoc safety and efficacy queries.
9. Use good pharmacovigilance practices to identify potential safety and efficacy signals for further investigation by the Pharmacovigilance Team.
10. Assist in the design of pharmacovigilance training materials and train on systems and pharmacovigilance policies as required
11. Any other PV activities as need arise and required by supervising manager
• Nursing, Veterinary Technician, Pharmacist qualifications, Degree in Life Sciences or two to five years experience in the pharmaceutical industry or another scientific environment
• Understanding of European / global regulatory requirements for veterinary pharmacovigilance a plus
• Case processing experience a plus
• Knowledge and experience of databases (preferably safety or regulatory or similar environments)
• Excellent knowledge of Microsoft Office
• Ability to work under pressure and in a highly matrix environment is essential
• Excellent organizational skills and attention to detail required
• Fluent written and spoken English, another EU language a plus
For more information, call Laura Schollen 04 94 04 21 32