The Pharmacovigilance Associate Specialist supports regional PV activities across LATAM, with a primary focus on follow‑up (FU) activities, ICSR submissions to Health Authorities, and other regional PV support activities as required. Under the oversight of the PV Manager or a designated PV colleague, the role contributes to the execution of day‑to‑day PV processes, ensuring compliance with local regulations and general/company procedures.
This position offers exposure to regional PV operations, case management, regulatory interactions, compliance activities, and cross‑functional collaboration, making it an excellent development opportunity for early‑career professionals in Pharmacovigilance.
- Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
- Activities may include but are not limited to management of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and submitting aggregate safety reports.
- Assists with day-to-day adverse events case management which may include case intake (where needed), translations (English and/or local language, (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.
- Supports local PV audits and inspections when requested.
- Participates in issue management/compliance activities and assists in coordinating/preparing the necessary local corrective actions.
- Supports development and maintenance of local PV procedures and controlled documents.
- Supports PV self-inspections as required by PV Legislations (where applicable).
- Supports appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per local procedure and local legislations.
- May be responsible for managing and performing local literature screening and assessment in accordance
📌 Drug Safety Specialist (Bogotá)
🏢 Msd
📍 Bogotá
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