Head Drug Safety and Pharmacovigilance (DS&PV)
We are seeking an experienced leader to oversee Santhera's global pharmacovigilance systems, ensuring compliance with all pharmacovigilance and quality obligations as a marketing authorization holder and clinical trial sponsor.
Key Responsibilities
1. Oversee Santhera's global pharmacovigilance system, ensuring compliance with regulations and managing pharmacovigilance vendors and activities.
2. Maintain a robust pharmacovigilance framework, ensuring timely identification, escalation, and management of safety concerns for all authorized and clinical-stage products.
3. Ensure high-quality safety reporting, including periodic safety update reports, risk management plans, and submissions to health authorities.
4. Collaborate with regulatory teams to address safety-related regulatory actions and respond promptly to health authority requests.
Requirements
* Medical, Scientific or equivalent degree.
* At least 10 years of experience in all aspects of drug safety and pharmacovigilance.
* Expert knowledge of European and US drug safety and pharmacovigilance requirements and strong knowledge in other geographical areas.
* Ability to work independently while being a reliable team player, managing multiple projects in a matrix environment.