As the Director* Pharmacovigilance & Risk Management, you will have the opportunity to formulate and implement regulatory strategies to support the development of several cutting-edge and personalized medicine technologies. Your main responsibilities are:
- Set up and implement the next level-strategy for our global pharmacovigilance and safety operations for a portfolio of products/programs, ensuring the development of safety processes, tools and system implementation
- Strategically develop and implement post-marketing pharmacovigilance processes and contribute to the product specific Risk Management Plan
- Represent the Company on co-development teams for assigned products/programs and liaison with co-development partners to ensure coordinated safety reporting activities
- Provide guidance to product/program teams and CROs for safety case review and adjudication.
- Participate in the review and interpretation of clinical trial results, particularly for understanding and interpretation of product safety