The Senior Manager, Pharmacovigilance (PV) will work under the supervision of the EU Director of PV Operations and partner with the US PV team, and EU QPPV to provide EU specific PV expertise.
The Senior Manager, PV will be responsible, in collaboration with the EU Director of PV Operations, EU, for setting up and maintaining the interaction between Clovis global PV department and the wider European network, consisting of local subsidiary offices, local PV contact persons/local QPPVs and other third parties. The Senior Manager, PV will therefore be responsible for maintaining the communication at all levels within the European network, ensuring that necessary safety information is received from and/or passed on to all relevant parties, and ensuring compliance with European PV requirements and with PV responsibilities as established within specific agreements. The Senior Manager, PV will also be responsible for providing PV training within the European network, as required.
- Support the global Clovis PV department through collation and dissemination of safety information internally and to external partners, as applicable
- Support the EU QPPV to establish PV system within the European network
- Work closely with Regulatory and Medical Affairs colleagues to ensure implementation and monitoring of effective risk minimization strategies within the European network
- Deputise for the EU Director of PV, as applicable, supporting the Director in daily PV tasks and responsibilities
- Contribute to the production, implementation of safety data exchange agreements and/or PV requirements within other types of agreements
- Ensure appropriate execution of safety data exchange agreements and/or PV requirements within other types of agreements with licensing partners and/or other parties
- Develop and maintain PV SOPs and Work Instructions, working closely with PV colleagues and Quality Assurance to ensure compliance with applicable EU legislation and guidance. Maintain inspection readiness via appropriate PV compliance monitoring for EU
- Support the EU Director of PV with maintaining and updating project plans
- Provide oversight of PV activities of local subsidiaries and other third parties
- Contribute to the periodic update of Clovis Pharmacovigilance System Master File (PSMF)
- Identify the need for and provide the necessary PV training within European network, ensuring compliance with PV requirements
- Represent PV Department as applicable
- Under the direction/review of senior PV staff, participate in other PV and Risk Management activities as necessary
- Assist EU Director of PV with activities related to regulatory inspections and audits