Global Patient Safety Director
Job Type: Contract – 12 Months
Location: South East Preferred
Cpl Lifesciences are looking for an Interim Global Patient Safety Lead/Director to join an exciting biotechnology company for a period of 12 months.
You will support products within the assigned portfolio. This position requires ability to work with and influence colleagues in a matrix environment and with senior management. This is a key member of the GPS team. This individual will have a major impact on drug development and commercialisation decisions, strategies and operations, in all relevant territories globally.
- Signal management; responses to regulatory agency queries; preparation, review and finalisation of safety documents
- Represent GPS for assigned compounds on cross-functional teams, including but not limited to Regeneron Safety Oversight Committee, Independent Data Monitoring Committees
- Proactively identify and develop plans/ strategies for non-compound specific Global Patient Safety activities.
- GMC Registered highly preferred.
- Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- Are able to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
- We are seeking individuals with extensive proven experience in GPS or equivalent including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with proven achievements in safety.