Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
This role provides medical and scientific leadership in the safety evaluation and risk management of GSK's Respiratory, Inflammation or Immunology (RII) assets in clinical development.
Key Responsibilities
- Lead pharmacovigilance and risk management activities for assigned GSK's RII assets and clinical trials
- Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle
- Analyse and interpret clinical data, literature, and emerging evidence to identify and assess safety signals
- Provide expert medical input into the safety components of global regulatory submissions
- Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit–risk decisions
- Ensure timely escalation of safety concerns in line with governance processes
- Represent Safety on cross-functional Clinical Matrix and Project Teams
- Lead cross-functional teams to address urgent and complex product safety issues
- Actively contribute to and, where appropriate, lead Safety Review Teams (SRTs)
- Build strong, collaborative relationships across functions and geographies
- Coach and mentor colleagues, contributing to capability development within the organisation
- Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders
- Lead presentations on safety issues and recommendations to senior governance committees
- Influence decision-making through clear, credible, and evidence-based communication
- Represent GSK in interactions with regulatory authorities, external experts, and partners
Why Join Us?
- Shape the safety strategy of innovative RII medicines
- Engage with senior governance and influence key development decisions
- Work within a highly collaborative, global matrix environment
- Contribute to scientific excellence and continuous improvement in safety science
Basic Qualifications
- Medical degree and relevant clinical experience
- Completion of formal postgraduate clinical training (e.g., residency or specialty training)
- Significant experience in pharmacovigilance, or drug safety
- Demonstrated expertise in signal detection, evaluation, and risk management
- Strong understanding of clinical development and post-marketing safety processes
- Experience working effectively in matrixed, cross-functional environments
- Excellent written and verbal communication skills, including preparation of medical and regulatory documents
- Strong clinical judgement and the ability to deliver clear, evidence-based recommendations
Preferred Qualifications
- Postgraduate specialisation in a clinical discipline or pharmaceutical medicine
- Experience contributing to regulatory submissions and periodic safety reports
- GMC Registration (if in UK)
- Knowledge of epidemiology, biostatistics, or real-world evidence relevant to safety assessment
- Experience leading Safety Review Teams or acting as safety lead for major programmes
- Prior engagement with regulatory authorities and external safety forums
- Demonstrated ability to coach and develop colleagues in medical, scientific, or safety roles