Senior Pharmacovigilance Associate
ICON plc · Sofia
Job description
About the role
ICON plc is seeking a Senior Pharmacovigilance Associate to lead drug safety activities across its European sites. You will ensure the safety and efficacy of pharmaceutical products by managing adverse event reporting, data integrity, and risk‑management processes.
Key responsibilities
- Lead collection, evaluation, and processing of adverse event reports in line with regulatory guidelines.
- Perform data entry, narrative writing, query management and quality control in the safety database.
- Collaborate with medical and clinical teams to assess clinical relevance of events and support risk‑management activities.
- Act as PV Lead on studies, serving as primary contact for clients and project managers.
- Maintain pharmacovigilance databases, ensuring accurate documentation and compliance.
- Provide training and mentorship to junior staff on PV processes and regulations.
- Support audits and inspections, ensuring readiness and compliance.
Required profile
- Strong foundation in pharmacovigilance and drug safety with ability to work independently.
- Bachelor’s degree in a scientific or healthcare‑related discipline.
- Extensive experience in PV, including adverse event reporting and signal detection.
- Excellent analytical, communication and interpersonal skills.
- Willingness to travel up to 15%.
Required skills
- Proficiency with pharmacovigilance databases and data‑management systems.
- Microsoft Office Suite.
What we offer
- Inclusive, innovative environment within a world‑leading healthcare intelligence organization.
- Opportunities for professional growth and mentorship.
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Published 1 day ago
Expires 1 month from now
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ICON plc
Sofia
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