Freelance Pharmacovigilance (PV) Auditor
Ergomed · Bogotá
Descripcion del puesto
About the role
We are seeking a freelance Pharmacovigilance (PV) Auditor to conduct audits for clients in the United States and Canada. The role can be full‑time or part‑time (minimum 0.6 FTE) and involves planning, executing, and reporting on PV audits.
Key responsibilities
- Plan, prepare, conduct, report and follow‑up on various types of PV audits, including CAPA plans, ensuring quality and timelines.
- Execute audits based on a comprehensive understanding of regulatory requirements and Good Pharmacovigilance Practice (GVP).
- Perform GVP quality‑assurance projects for pharmaceutical and biotechnology client companies.
Required profile
- Proven experience leading internal and external Pharmacovigilance audits for diverse stakeholders.
- Expert knowledge of national and international PV legislation and guidelines.
- Strong project‑management skills with ability to deliver timely audit deliverables.
- Pragmatic problem‑solving ability to identify issues and propose solutions.
- Bachelor’s degree in Life Sciences preferred.
- Willingness to travel up to 40 % and conduct remote audits.
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Publicado hace 2 horas
Expira en 1 mes
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Ergomed
Bogotá