MSI are working with a small biopharma company to help source a experienced PV Operations Manager, based in Munich, Germany.
Key Responsibilities:
- Ensure constellation and vendors are audit-ready at all times
- Ensures adverse events are accurately processed and reported within timelines per country-specific requirements
- Executes PV Operational strategy for safety data collection, processing and review across all programs
-Develop, implement, improve and standardise new processes, methods, and databases
- Collaborates with Clin. Ops and investigate sites to ensure complete and accurate event reporting
- Oversee the set-up of safety aspects of new clinical trials including study-specific Safety Management Plans and Periodic Reporting plans
- Provides clinical trial safety oversight and support including the support of database lock clean-up activities for AEs/clinically significant laboratory values
- Manages the third party PV Vendor outsourced Clinical Trials Safety activities
- Provides sponsor oversight of PV Vendors SAE processing including the review and monitoring of compliance and other oversight activities and ensures the implementation of effective CAPA's
- Ensures compliant exchange of safety data between constellation and its partners
- Ensures the timely preparation, review ans submission of aggregate safety reports
- Provides support for external submissions, signal detection and risk management planning activities
- Monitors compliance with regulations, PV agreements and internal SOPs
- Prepares governing documents such as SOPs, work instructions and safety management plans
- Collaborates with Medical Affairs personnel on Investigator Sponsored programs as required
- Performs PV quality management system activities including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practice
- Works with QA department to maintain a state of PV inspection readiness across all regions/countries
-Participates in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes
