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PV Operations Manager

PV Operations Manager

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PV Operations Manager

  • Location:

    Eurasburg

  • Sector:

    Pharmacovigilance - Pharma

  • Contact:

    Denise Carroll

  • Salary:

    Up to €66000 per annum + Competitive

  • Job type:

    Permanent - full time

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04188_1669051795

  • Published:

    16 days ago

  • Startdate:

    ASAP

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