Pharmacovigilance Manager
4 settimane fa
At Glaxosmithkline, we are seeking a highly skilled Pharmacovigilance Manager to join our team. As a Pharmacovigilance Manager, you will play a critical role in ensuring the safety of our products and providing high-quality pharmacovigilance services to our customers.
Key Responsibilities
• Support the Medical Director and Head of Scientific Services in overseeing the company's patient safety risks, including a review at the local Risk Management & Compliance Board, in collaboration with the Named Safety Contact.
• Ensure the management of pharmacovigilance activities in charge of the LOC for marketed and clinical development products, whether they are ethical drugs, vaccines, ensuring compliance with local regulatory laws and Group Policies/Procedures.
• Assume the responsibilities provided by Italian law for the role of Responsible for Pharmacovigilance (FV).
Requirements
• Interact with AIFA and regional pharmacovigilance centers regarding human safety issues and related actions.
• Interact with the Central Safety Department/Global Regulatory regarding issues or requests from AIFA on GSK products, including the management of urgent safety communications such as DIL/DHCP, safety information requests, educational materials, etc.
• Interact and collaborate with global functions, and the external central supplier as needed, and maintain oversight of activities conducted by the supplier, in order to ensure accountability of the LOC in pharmacovigilance. This person is the liaison with partner companies (ViiV) regarding intercompany agreements and updating GM/functions interested in safety matters.
Desirable Skills
• Knowledge of sector regulations and laws, as well as company policies (Ethical & Legal Compliance).
• Knowledge of research clinical processes, pharmacovigilance, medical information, and pharmaceutical product development processes.
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