We are partnered with an innovative, fast-growing biotech based in Basel, searching for a Head of PV with global oversight on PV compliance.
- Responsible for global PV strategy and team management and for compliance with safety regulations (knowledge of EU regulations and also non-EU regulations required).
- Monitor audit responses and Corrective and Preventive Actions (CAPAs) to ensure accuracy and completeness.
- Act as PV QA representative in designated global drug safety team activities and internal guidance and consulting for GVP issues.
- Preparation of periodic reports (PSUR, ACO, PMCFER) and RMPs (Risk Management Plans).
- Creation, maintenance and updating of SOPs, Pharmacovigilance System Master File (PSMF), pharmacovigilance contracts, etc.
- Updating of product information from the point of view of drug/medical device safety.
- Internal departmental quality control and assurance (deviations and CAPA, audit management), documentation of tasks arising in the department.
- 7-10 years + experience within pharmacovigilance / drug safety
- Medical device safety experience also desirable.
- You have a sound knowledge of the relevant local and EU-wide standards and directives (GVP, AMG, MDR, MEDDEV, etc.).
- Fluent English.
- You have good knowledge of MS-Office and experience with databases.
- You have a reliable, precise and responsible way of working, as well as communication skills and are a good team player.