Global Pharmacovigilance Compliance Lead
In this strategic role, you will drive enhanced compliance across the pharmacovigilance domain. You will oversee and manage PV audit programs, ensuring a standardized approach is implemented and maintained across all sites.
This leadership position requires strong expertise in international pharmacovigilance regulations, as well as a deep understanding of pharmaceutical industry practices. The ideal candidate has at least 10 years of experience in QA/industry roles, including PV audits, coordination of pharmacovigilance inspections, and training employees on GVP requirements.
The successful candidate will be responsible for:
* Acting as a primary contact with internal stakeholders, establishing effective relationships, driving collaboration, and providing expert-level PV knowledge.
* Leading project initiatives and providing strategic advice to internal or external stakeholders.
* Maintaining high-level knowledge of current global pharmacovigilance regulations and updates.
* Evaluating changes to country-specific laws and regulations related to PV.
We are seeking a highly skilled professional with expertise in pharmacovigilance/drug safety, a master's degree in a relevant scientific discipline, and excellent communication skills.
Requirements
* Master's degree in a relevant scientific discipline (Pharmacy or other fields).
* At least 10 years of experience in QA/industry roles, including PV audits, inspections, and training on GVP requirements.
* Expert knowledge of international pharmacovigilance regulations (EU, US, Health Canada & ICH guidelines) of medicinal products for human use.
* In-depth knowledge of pharmaceutical industry practices.
* Fluent in English; German and French would be advantageous.