Principal Safety Scientist - SERM
About The Position
Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
Requirements
- Degree in a health or life sciences discipline or healthcare professional qualification (for example, PharmD, PhD, RN, RPh, BSc) or equivalent experience.
- Experience in pharmacovigilance, safety evaluation, clinical safety or a related role in the pharmaceutical or biotech industry.
- Practical knowledge of safety evaluation methods, signal detection principles and adverse event reporting.
- Experience with clinical development and post-marketing safety activities.
- Good clinical and scientific literacy, including understanding of medical terminology and study design.
Nice To Haves
- Advanced medical or scientific degree (for example, PhD, MSc) or clinical training.
- Experience authoring or contributing to regulatory safety documents and risk management plans.
- Experience working across global teams and multi-country safety requirements.
- Familiarity with pharmacovigilance regulations and guidance in global regions.
- Experience with safety databases and safety signal detection tools.
Responsibilities
- Leads signal detection and evaluation activities for assigned products.
- Produces clear, accurate, and fit-for-purpose safety evaluations in response to internal and regulatory requests.
- Contributes to Risk Management Plans (RMPs), risk assessments, and safety documentation in collaboration with senior colleagues.
- Authors and reviews global periodic safety reports, aggregate reports, protocols, and other regulatory documents within agreed timelines.
- Participates in process improvement initiatives and ensures timely completion of audit and inspection follow-up activities.
- Utilizes multiple data sources to investigate safety issues, propose solutions, and support decision-making in consultation with SERM physicians.
- Effectively prioritizes workload, manages competing deadlines, and consistently delivers high-quality outputs with minimal supervision.
- Builds strong collaborative relationships across functions to address product safety matters.
- Supports Safety Review Teams (SRTs) and governance activities in both development and post-marketing settings, helping to identify, evaluate, and mitigate safety risks.
- Contributes to the implementation of risk minimization strategies in clinical protocols and product labeling.
- Demonstrates strong verbal, written, and medical/scientific communication skills, producing high-quality evaluations and reports.
- Supports and communicates safety risk positions clearly to internal and external stakeholders.
Benefits
- annual bonus
- eligibility to participate in our share based long term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Principal
