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Medical Director

2 mesi fa

Siena, Toscana, Italia GlaxoSmithKline A tempo pieno
About the Role

We are seeking a highly skilled and experienced Medical Director to join our team at GlaxoSmithKline. As a key member of our safety evaluation and risk management team, you will be responsible for providing medical and scientific expertise to support the development and commercialization of our pharmaceutical products.

Key Responsibilities
  • Signal Detection and Evaluation: Responsible for detecting and evaluating signals related to the safety of our products, including the identification of potential risks and the development of strategies to mitigate them.
  • Regulatory Reporting: Drives the production of regulatory periodic reports and associated documentation, ensuring compliance with international pharmacovigilance requirements and global regulatory standards.
  • Safety Governance: Supports and facilitates safety governance and risk management activities, including the establishment and operation of cross-functional teams to detect and address product safety issues.
  • Process Improvement: Leads or participates in process initiatives to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.
  • Communication: Presents complex safety issues to senior staff members at the GSK Senior Governance Committees.
Requirements
  • Medical Qualifications: Medical Doctor (physician), with additional relevant medical or scientific post-graduate qualifications.
  • Pharmacovigilance Experience: Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
  • International Requirements: Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
What We Offer

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We also offer a hybrid working model, empowering you to find the optimal balance between remote and in-office work.