Pharmacovigilance Quality Assurance Support (60%)
My client is an innovating, dynamic and growing international CRO with key expertise in Clinical Trial, regulatory affairs and Pharmacovigilance currently expanding their Pharmacovigilance team in the French part of Switzerland.
Due to this growth of activities my client is looking for a Pharmacovigilance Quality Assurance Support (60%) for a contract of minimum 1 year.
– Management of non-compliance and CAPA
– Establish PV audit planning, PV audit management and remote PV audit execution and reporting
– Support to PV SOP development and review
– Contribute the quality check of DSUR, PSUR, RMP, PSMF
– Master degree or equivalence in pharmacovigilance.
– Minimum 3 years experience in pharmacovigilance and pharmaceutical company.
– Strong experience with aggregate reports and PV audits.
– Strong communication skills, proficiency in English, any other language is an asset