04 ott - Reggio Emilia
Chiesi Farmaceutici
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 ind
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