Product Safety Review Consultant
One Baxter Parkway Deerfield IL USA 60015 Riverwoods, IL 60015 US
This is a position in the Pharmacovigilance Agreements (PVA) team in the QPPV Office. It has direct responsibility for management of the formulation, review, update, and compliance of Pharmacovigilance Agreements (PVAs) for potential and active External Party activities across all therapeutic areas in the Americas region (US, Canada, Latin America). This role manages all workflows related to PVAs in the region in collaboration with the regional business, Patient Safety, and other functions, as well as the process requirements for registering all patient support and market research programs (PSP/MRP) with GPS in the region.
Essential Duties and Responsibilities.
- 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 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 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.
- Support development and implementation of systems and processes to monitor External Party compliance with PVAs
- 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 (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.
- Expert knowledge of pharmacovigilance principals with at least 5 years working knowledge of regional/local and global pharmacovigilance regulations and guidance documents.
- Experience with contract formulation and negotiation.
- Excellent oral and written communication skills
- Excellence in English language (oral and writing). Excellence in Spanish (oral and writing) is an advantage.
- Expert interpersonal and collaboration skills, including ability to interface with and influence other groups (e.g. Business Franchises, Quality, Regulatory, Legal, etc.)
- Ability to manage projects in a matrix environment with both internal and external partners
- Demonstrates proven ability to effectively train and mentor others
- Excellent technical system skills (e.g. word processing, spreadsheets, databases, Share Point, online research)
- Exercise independent judgment and attention to details
- Excellent problem-solving/strategic planning skills, interpretation and application of regulations, guidance, and best practices.
- Proven experience in developing compliance tracking processes, systems, and metrics.
- Establish compliance with pharmacovigilance procedures and systems and demonstrate leadership in assigned areas of responsibility.
Education and/or Experience:
- Bachelors degree, or more advanced degree in relevant life science discipline, e.g. Pharmacist or Registered Nurse.
- Minimum of 5 years experience in the pharmaceutical industry in pharmacovigilance (preferred) and/or related field required. (e.g. regulatory or medical/clinical affairs, legal, quality).
- Minimum 3 years experience with negotiation, creation, and management of Pharmacovigilance Agreements
- Exposure to working relationship with regulatory authorities in the Americas and other region
- Fluent in English.
- Fluence in Spanish and/or Portuguese is an advantage.
- Experience managing projects
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.