Pharmacovigilance Auditor – Freelance (0.6+ FTE)
ADAMAS Consulting · Sofia
Описание на позицията
About the role
ADAMAS Consulting is seeking an experienced Pharmacovigilance Auditor on a freelance basis to conduct PV audits for pharmaceutical and biotechnology clients across Europe. The role can be full‑time (1 FTE) or part‑time (0.6 FTE or more) and involves both on‑site and remote engagements.
Key responsibilities
- Plan, prepare, execute and report on a variety of Pharmacovigilance audits, ensuring quality and timelines.
- Develop and follow up corrective and preventive action (CAPA) plans after audit findings.
- Perform GVP quality‑assurance projects for client companies.
- Interpret and apply national and international PV legislation and Good Pharmacovigilance Practice guidelines.
Required profile
- Proven experience leading internal and external Pharmacovigilance audits for diverse stakeholders.
- Deep knowledge of PV legislation and GVP guidelines.
- Strong project‑management capability with timely delivery of audit deliverables.
- Ability to identify issues and propose pragmatic solutions.
- Bachelor’s degree in Life Sciences preferred.
- Willingness to travel for on‑site audits, with remote audit options available.
Required skills
- Good Pharmacovigilance Practice (GVP) compliance
- Pharmacovigilance regulatory knowledge
- Project management
What we offer
- Flexible freelance contract (full‑time or part‑time)
- Opportunities to work with leading life‑science companies across Europe
- Collaborative and supportive consulting environment
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ADAMAS Consulting
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