Qualified Person Responsible for Pharmacovigilance (QPPV) in EU & UK
Ergomed · Zagreb
Opis radnog mjesta
About the role
PrimeVigilance, a specialised mid‑size pharmacovigilance service provider, is seeking an EU Qualified Person Responsible for Pharmacovigilance (QPPV) to lead safety activities across the European Union and the United Kingdom. This home‑based position ensures the company meets regulatory obligations while supporting global clients.
Key responsibilities
- Establish and maintain a system to collect and collate suspected adverse reaction information across the EU.
- Respond promptly to competent authority requests for additional information needed to evaluate medicinal product benefits and risks.
- Provide authorities with relevant safety information, including data for post‑authorisation safety studies.
- Remain continuously available to competent authorities and ensure adequate backup procedures.
- Oversee safety aspects of the company’s medicinal products, monitor safety profiles and emerging concerns.
Required profile
- Life‑science education (Medicine or Pharmacy preferred).
- Solid knowledge of pharmacovigilance system operations and functions.
- Strong understanding of global regulations, standards and best practices for safety processing and reporting.
- Demonstrated operational and managerial skills, with experience leading projects or functions.
- Extensive experience in a PV role, including proven experience as a QPPV.
- Excellent oral and written communication skills in English.
What we offer
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment.
- Opportunity to work with colleagues worldwide, with English as the company language.
- Core values focused on quality, integrity, trust, drive, passion, agility, belonging and collaborative partnerships.
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