15 ago - Parma
Chiesi Farmaceutici
R&D; GRAPS Affiliate and Partnership Oversight Unit Head 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. 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 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 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 Effective planning, organisational and analytical skills Demonstrated ability to work with cross‑functional teams, with a clear result‑oriented approach and attention to detail Office package; safety database and other data‑management systems 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 can be flexible. 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. 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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