Local Contact Person for Pharmacovigilance (Freelance)
Allucent
Job description
About the role
Allucent™ is building a network of local pharmacovigilance experts to support small‑medium biopharmaceutical companies. As a Freelance Local Contact Person for Pharmacovigilance (LCPPV) in Poland, you will coordinate logistical PV activities, ensure compliance with local regulations, and act as the primary liaison with regulatory authorities.
Key responsibilities
- Serve as the main point of contact for local regulatory authorities, including 24/7 availability when legally required.
- Monitor safety issues, regulatory recommendations, and legislative changes affecting client products.
- Support client audits and inspections, provide documentation, and manage corrective actions.
- Conduct local literature screening and collect safety information.
- Assist in developing or reviewing the local pharmacovigilance system master file (LPSMF).
- Support local signal detection and risk‑minimization measures.
- Maintain regular communication with the EU QPPV and review local PV agreements.
- Deliver PV training to sales forces, affiliate personnel, and distributors.
- Prepare monthly activity reports on the status of the local PV system.
Required profile
- University degree in medicine, pharmacy, life sciences or related field.
- Minimum 2 years of experience in post‑marketing pharmacovigilance activities.
- Current knowledge of global and Polish regulatory requirements.
- Fluency in written and spoken English.
- Residency in Poland.
Required skills
What we offer
- Freelance, part‑time opportunities within a growing PV network.
- Collaboration with a team that values expertise and personal impact.
- Access to diverse projects across the biopharma sector.
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Published 1 mánuður síðan
Expires 3 dagar síðan
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