Senior Pharmacovigilance Specialist
Biomapas
Job description
About the role
We are looking for a Senior Pharmacovigilance Specialist to join our global PV team. The role is fully remote and supports both global and local pharmacovigilance systems, ensuring compliance with international and local regulations.
Key responsibilities
- Act as Project Manager or Deputy Project Manager for assigned PV projects.
- Perform accurate forecasting and contribute to budget planning for the QPPV Office.
- Update SOPs and serve as a subject‑matter expert for PV processes.
- Maintain KPI reports and execute core PV activities for contractual partners.
- Manage full or local pharmacovigilance systems, including case processing, aggregate safety reports, risk management plans, and risk‑minimisation activities.
- Serve as the primary customer contact point, handling communication and escalation.
- Act as appointed EU QPPV or Deputy EU QPPV when required.
- Ensure high‑quality PV service delivery, audit readiness, and timely communication with Health Authorities.
Required profile
- Degree in Biology, Pharmacy, Medicine or another life‑science discipline.
- At least 4 years of experience in global pharmacovigilance activities.
- Fluent English (written and spoken).
- Strong organizational, time‑management and independent‑working abilities.
Required skills
- Proficiency with MS Office.
- Experience with pharmacovigilance databases; Veeva Vault Safety is a plus.
What we offer
- Professional growth and career opportunities within an international team.
- Performance‑based bonus.
- Personal accident, business‑trip and additional health insurance.
- Fully remote work with a workplace‑establishment allowance.
- Rewarding referral policy and participation in global team‑building events.
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Published 1 month ago
Expires 3 weeks from now
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