Safety Evaluation & Risk Management (SERM) Scientific Director
Locations: London, United Kingdom | Alipurduar, India | Warsaw, Poland
Employment Type: Full Time
Category: Medical & Clinical
Experience Required: 10+ years in Pharmacovigilance / Drug Safety / Risk Management
About GSK PLC
GSK PLC is a global biopharmaceutical leader committed to uniting science, technology, and talent to advance healthcare worldwide. Our mission is to positively impact the health of 2.5 billion people by the end of the decade through innovation in vaccines and specialty medicines. At GSK, employees thrive in a collaborative and inclusive environment, contributing to meaningful work that transforms patients’ lives.
Position Summary
GSK is seeking a SERM Scientific Director to provide expert medical and scientific leadership in safety evaluation and risk management for key assets across clinical development and post-marketing stages. The role focuses on ensuring patient safety globally by analyzing safety data, managing safety risks, and implementing risk-reduction strategies while supporting pharmacovigilance and benefit-risk management across GSK’s portfolio.
Key Responsibilities
Scientific and Medical Expertise
Lead pharmacovigilance and risk management planning for assigned assets.
Provide expert evaluation of clinical, non-clinical, and literature data to detect and interpret safety signals.
Author and review scientifically robust benefit-risk assessments, safety reports, and regulatory submissions.
Make data-driven recommendations to senior management and safety governance on safety risk characterization and mitigation.
Cross-Functional Leadership
Lead cross-functional safety governance and matrix teams to address clinical development and post-marketing safety issues.
Facilitate safety-related discussions and decision-making across project teams and senior committees.
Mentor and coach team members, fostering collaboration and knowledge sharing.
Contribute to process improvement initiatives and ensure alignment with global regulations and internal SOPs.
Communications and Stakeholder Engagement
Represent GSK in safety discussions with regulatory authorities, partners, and external stakeholders.
Deliver presentations and recommendations on safety strategies to senior governance committees.
Provide strategic insights to influence clinical programs, risk management, and long-term safety strategy.
Required Qualifications & Experience
Bachelor’s or higher scientific degree (BSc, MSc, PharmD, MD, or equivalent).
Minimum 10 years of experience in pharmacovigilance, drug safety, or risk management within pharmaceutical or biotech industries.
In-depth expertise in safety evaluation, signal detection, and risk management across clinical development and post-marketing stages.
Strong knowledge of international pharmacovigilance regulations (ICH, GVP, CIOMS) and drug development processes.
Proven ability to lead cross-functional teams in a matrix environment and influence stakeholders at all levels.
Experience in vaccine safety is highly desirable.
Preferred Skills
Advanced analytical and decision-making skills with a track record of scientific problem-solving.
Excellent communication, presentation, and influencing capabilities in a multicultural environment.
Ability to manage multiple complex projects simultaneously with adherence to timelines and quality standards.
Why Join GSK?
Competitive base salary with annual performance-based bonus.
Flexible working options and hybrid work models.
Comprehensive learning and career development programs.
Access to healthcare and wellbeing initiatives.
Inclusive, supportive, and collaborative global work culture.
Gujarat :
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