Reference Number: JO-2102-462967
Global Patient Safety Lead
Job Type: Contract
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.
If you would like to learn more about this opportunity please email today on firstname.lastname@example.org.