R&D GRAPS Affiliate and Partnership Oversight Unit Head

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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 research organisation
- Excellent communication, interpersonal, negotiation and leadership skills
- Proven ability to manage contracts and keep multiple tasks and projects on track
- Strategic thinking, problem‑solving and decision‑making skills
- Effective planning, organisational and analytical skills
- Demonstrated ability to work with cross‑functional teams, with a clear result‑oriented approach and attention to detail
- Ability to organise and prioritise tasks both individually and across the team to achieve established deadlines while maintaining high quality performance
- IT skills: Office package; safety database and other data‑management systems

Preferred Qualifications





- Expert knowledge of domestic and international regulatory safety information management
- Pharmacovigilance alliance management experience
- Up‑to‑date knowledge of global regulations (Good Clinical and Good Pharmacovigilance Practices), policies and procedures and legal requirements to ensure compliance

Location

Location can be flexible.

Compensation range

The minimum salary for this role is €62,000, aligned to the established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual premio scheme, subject to company and individual performance.

Benefits

In addition to the base salary, we offer a comprehensive benefits package including pension, private medical insurance, well‑being programme, flexible benefits programme and more. Options for flexible working arrangements, remote work, and tax assistance services for foreign colleagues are also available.

Equal Opportunity Employer

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78s8lz