Director of Clinical Safety and Pharmacovigilance

2 months ago


London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Summary

We are seeking a highly experienced and skilled Director of Clinical Safety and Pharmacovigilance to join our team at GlaxoSmithKline. As a key member of our Global Safety organization, you will be responsible for leading medical and scientific staff within the Safety Evaluation and Risk Management (SERM) department.

Key Responsibilities
  • Strategic Leadership: Develop and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.
  • Policy and Process Implementation: Implement policy, processes, and support the implementation of operational and strategic plans.
  • Data Review and Interpretation: Ensure scientifically sound review and interpretation of data and management of safety issues, escalating safety issues identified through the safety review process to senior management and safety governance as appropriate.
  • Pharmacovigilance and Benefit-Risk Management: Support the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Requirements
  • Expertise in Clinical Safety and Pharmacovigilance: Proven experience in clinical safety and pharmacovigilance activities, with a demonstrated record of sound judgment and decision making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and proactive risk management strategies.
  • Leadership and Coaching: Ability to coach and mentor SERM colleagues in the scientific and medical aspects of signal evaluation methodology and risk management, and preparation of regulatory safety reports and other documents.
  • Quality Decision Making: Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
  • International Pharmacovigilance Requirements: Knowledge and experience of international pharmacovigilance requirements, including compliance with regulatory guidelines and industry standards.
What We Offer

As a Director of Clinical Safety and Pharmacovigilance at GlaxoSmithKline, you will have the opportunity to work with a talented team of professionals who are passionate about improving patient safety and outcomes. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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