R&D GRAPS Affiliate and Partnership Oversight Unit Head
Pubblicato il 06-08-2026 - Biotecnologie - Farmacia - Chimica in Italia
R&D; GRAPS Affiliate and Partnership Oversight Unit Head
Location: Parma, IT
Responsibilities
Assure that relationships with Partners and Affiliates are duly managed in the light of patient safety related matters and regulations both at global and local level to ensure compliance with worldwide regulatory requirements and company policies.
You will be responsible for
Contribute to the strategy for SDEAs and as applicable, Intracompany Agreement program management
Build collaborative working relationships with business development, alliance management and legal department to enable timely identification of contracts requiring SDEA development
Act as the main point of contact for matters relating to SDEAs, Intracompany Agreements, and/or license partners providing advice and guidance on contracts generation in collaboration with the Head of Affiliate Network
On‐going interface with contractual partners regarding contractual issues during the lifetime of a project
Act as primary subject matter expert during audits or regulatory authority inspections; coordinate any necessary CAPA actions stemming from partner audits or inspections
Ensure all SDEAs are kept current and re‐negotiations or terminations are initiated and completed in a timely fashion
Liaise with R&D; PV QA regarding audit strategy for business partners
Author or contribute to procedures for SDEA development and maintenance and ensure maintenance of templates and procedures in line with regulations and company policies
Ensure the implementation and maintenance of adequate tracking tools for SDEAs
Ensure that the relevant annexes of the Pharmacovigilance System Master File (PSMF) are updated
Organize the periodic Global Safety and Compliance Council together with the Compliance and Process Unit Head
Qualifications
Master's Degree in life sciences, pharmacy or related fields
Minimum 5–7 years of experience in international pharmacovigilance within the pharmaceutical, biotechnology industry and/or contract resea