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Clinical Risk Manager

1 month ago

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

This position supports the evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting, focusing on therapeutic areas such as Respiratory, Infectious Diseases/HIV, Hepatitis/Fibrosis, and Neurology/Dementias.

The successful candidate will provide in-depth medical/scientific expertise, ensuring scientifically sound review and interpretation of data and management of safety issues, and escalating safety issues to senior management and safety governance as appropriate.

Key Responsibilities

Scientific/Medical Knowledge PV Expertise

  • Develops and leads Pharmacovigilance and Risk Management Planning, and develops strategy for approach to evaluation of issues in the clinical matrix.
  • Leads the safety component of global regulatory submissions, ensuring compliance with international pharmacovigilance requirements.
  • 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.

Cross-functional Matrix team leadership

  • Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings, anticipating, detecting, and addressing product safety issues.
  • Facilitates safety governance/SRTs in the clinical development and post marketing settings, assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues.
  • Represents GSK on cross-functional Clinical Matrix Teams and/or Project Teams, leading cross-functional ad hoc teams to address urgent and important 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.
  • Accountable for the escalation of issues and communication on safety matters, building strong working relationships and displaying excellent leadership skills on safety issues while working in a matrix team.

Communications (verbal, written) and Influencing (internal PV Governance and External LTs)

  • Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees, representing GSK and contributing to safety-related discussions at meetings with regulatory authorities, outside consultants, and other companies.
  • Leads inspection readiness and prepared as needed to support audits/inspections, ensuring compliance with international pharmacovigilance requirements.