Description:
What you'll be doing:
- Communicate and negotiate directly with co-developers/co-marketers/partners (e.g. distribution partners) and patient support program (PSP) / market research program (MRP) vendors (External Parties) related to development, implementation and maintenance of PVAs
- Support development and maintenance of standard PVA templates for use at global and local level.
- Collaborate with other Baxter businesses/functions and GPS to ensure that
-new/planned business/commercial relationships are notified to GPS
- agreements appropriately address PV obligations.
- Inform GPS teams of new PVAs, including PVA commitments and contractual obligations, and any changes to existing PVAs
- Train local PS staff and other Baxter internal staff, as required, on PV obligations in new or updated PVAs/PSPs/MRPs and on process. Support planning, development, and maintenance of training material.
- Make registrations for Americas region in the PVA global repository and the PSP/MRP global repository, in collaboration with local PS when required.
- Answer internal (GPS) and external (Baxter business and External Party) questions related to PVAs and PSPs/MRPs registered with GPS,
- Ensure implementation of and support maintenance of GPS Global Quality Procedures (GQPs) and Guidance Documents/Job Aids related to External Party Agreements (PVAs, PSP/MRP agreements).
- Provide support as subject matter expert regarding PVAs and PSPs/MRPs for internal audits and external inspections by regulatory authorities in the region, as required.
What you'll bring:
- Bachelor’s degree, or more advanced degree in relevant life science discipline, e.g. Pharmacist or Registered Nurse.
- 5+ years’ experience in the pharmaceutical industry in pharmacovigilance (preferred) and/or related field required. (e.g. regulatory or medical/clinical affairs, legal, quality).
- Must have 2+ years´ experience with negotiation, creation, and management of Pharmacovigilance Agreements.
- Exposure to working relationship with regulatory authorities in the Americas and other region.