Overview
In this role you will provide medical and scientific input for safety evaluation and risk management across clinical development and post-marketing. You will lead signal detection, produce safety assessments, and contribute to risk management plans and safety documents. You’ll collaborate across functions to support pharmacovigilance and patient safety globally, potentially leading a team. This is a mission-driven position at a company accelerating assets to improve patient outcomes.
Pay / Benefits
- annual bonus
- share-based long-term incentive program
- flexible working culture
- relocation support (to Cambridge)
- competitive base salary
Responsibilities
- Lead signal detection and evaluation for assigned products
- Produce safety evaluations in response to internal and regulatory requests
- Contribute to Risk Management Plans, risk assessments, and safety documentation
- Author and review global periodic safety reports and protocols within timelines
- Support process improvements and audit/inspection follow-up activities
- Utilize multiple data sources to investigate safety issues and inform decisions
- Prioritize workload to deliver high-quality outputs with minimal supervision
- Foster cross-functional collaboration with Safety Review Teams and governance activities
- Contribute to risk minimization strategies in protocols and labeling
- Communicate safety risk positions to internal and external stakeholders
Key requirements
- Degree in health or life sciences or healthcare professional qualification (e.g., PharmD, PhD, RN, RPh, BSc) or equivalent experience
- Experience in pharmacovigilance, safety evaluation or related role in pharma/biotech
- Practical knowledge of safety evaluation methods, signal detection, adverse event reporting
- Experience with clinical development and post-marketing safety activities
- Good clinical and scientific literacy and understanding of study design
- Strong verbal and written communication
- Cross-functional collaboration
- Leadership and team management (if applicable)
- Pharmacovigilance
- Safety evaluation and signal detection
- Risk management plans (RMPs)
Principal Safety Scientist - SERM in Irvine employer: GSK
GSK is an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of Stevenage. With a strong commitment to employee growth, you will have access to extensive development opportunities while working on groundbreaking medicine projects. The hybrid work model and future relocation to Cambridge provide a unique advantage, ensuring a vibrant environment for both personal and professional advancement.
