Scientific Director

4 weeks ago


London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Title: Associate Director

GlaxoSmithKline is seeking a highly skilled Associate Director to join our team in the Safety Evaluation and Risk Management department. As a key member of our team, you will be responsible for providing scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.

Key Responsibilities:
  • Ensure scientifically sound review and interpretation of data and management of safety issues, and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate.
  • Production of regulatory periodic reports and associated documentation globally according to the agreed process and timelines; advise on content of regulatory period reports.
  • Safety contribution to global regulatory submissions, including Risk Management Plans.
  • Ensuring risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
  • Making recommendations for the further characterization, management, and communication of safety risks.
  • Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing clinical development and/or post-marketing activities.
Requirements:
  • Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing clinical development and/or post-marketing activities.
  • Knowledge/experience of international pharmacovigilance requirements.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.


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