Medical Director

1 week ago

London, Greater London, United Kingdom GlaxoSmithKline Full time

Job Description:


Safety Evaluation and Risk Management:


The ideal candidate will provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.


Key Responsibilities:



  • Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
  • Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.
  • Responsible for signal detection and evaluation activities for assigned products.
  • Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines.
  • Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.
  • Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
  • Makes sound decisions based on relevant information or factors gathered from a broad range of sources.
  • Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail.
  • Supports and Facilitates safety governance/SRTs in the clinical development and post-marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues.
  • Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.
  • Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team.
  • Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.

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