International pharmaceutical company is opening global role of Senior PV Compliance Specialist.
Are you interested in job opportunity where you can use your experience in this specific area as is Pharmacovigilance & legal area?
As Senior PV Compliance Specialist you will be responsible for:
- Arranging consent on pharmacovigilance agreements for the collaboration between PV and external partners
- Contributes to and reviews the creation or revision of contracts (e.g. development, license, distribution agreements)
- Managing, negotiating documents - PV agreements in collaboration with representatives from partner companies
- Collaborating with PV functions, QPPV Office, Legal Department, specific country organizations and other business units as required
- Gathering information from internal functions to develop a strategy for the content of pharmacovigilance agreements and the negotiations of the agreements
- Obtaining internal consent for content of PV agreements
- Developing of standards for information exchange with partners in cooperation with PV functions
- Leading development of standard contract templates in cooperation with the Legal Department and PV functions
- Collecting pharmacovigilance-relevant contracts, initiate creation or revision of PV agreements as appropriate
- Work with pharmacovigilance-relevant contracts and PV agreements into the repositor(maintain relevant master data for search and retrieval activities)
- Be in charge of periodic review of adequacy of existing PV agreements
- Supporting the QPPV Office with information about PV agreements for inclusion into the PV system master file
- Be in charge of implementation of obligations deriving from PV agreements throughout PV functions
- Monitoring adherence to PV agreements of PV Functions and external partners (communicate issues & suggest, request corrective actions)
- Communication with external partners to ensure legal and regulatory compliance
- Co-working with audit functions to ensure comprehensive auditing of license partners (goal is to reach compliance with PV agreements)
- Providing relevant information concerning PV agreements to internal audits and inspections
- Representing PV in due diligences and manage transfer of pharmacovigilance activities as appropriate
- Negotiation & organising of PV activities