Director, Data Quality and Safety Expert

6 days ago


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

We are seeking a highly skilled and experienced professional to join our team as a Director, Data Quality and Safety Expert. This role will be responsible for providing in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.

Key Responsibilities
  • Lead Pharmacovigilance and Risk Management Planning and develop strategy for approach to evaluation of issues in the clinical matrix.
  • Lead the safety component of global regulatory submissions.
  • Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
  • Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
  • Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
  • Facilitate 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 and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
  • Represent GSK on cross-functional Clinical Matrix Teams and/or Project Teams. Lead cross-functional ad hoc teams to address urgent and important product safety issues.
  • Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
  • Experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance.
  • Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
About GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). As an Equal Opportunity Employer, we are open to all talent. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.


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