Safety Evaluation & Risk Management (SERM) Scientific Director
Location: Bengaluru, India | Warsaw, Poland
Employment Type: Full-Time
Job Category: Medical Affairs | Pharmacovigilance | Clinical Safety
Job ID: 429061
Posted Date: January 22, 2026
About the Company
GSK is a global biopharmaceutical leader committed to uniting science, technology, and talent to get ahead of disease together. With a strong focus on innovation, patient safety, and global health impact, GSK develops and delivers specialty medicines and vaccines across key therapeutic areas including respiratory, immunology, oncology, HIV, and infectious diseases.
Position Summary
The Safety Evaluation & Risk Management (SERM) Scientific Director provides senior-level medical and scientific leadership in the safety evaluation, benefit-risk assessment, and risk management of GSK’s global portfolio. This role supports both clinical development and post-marketing pharmacovigilance activities, ensuring robust safety governance and patient safety worldwide.
The incumbent will lead safety strategy, oversee signal detection and risk mitigation, contribute to global regulatory submissions, and engage with internal governance bodies and external regulatory authorities.
Key Responsibilities
Safety Evaluation & Pharmacovigilance Leadership
Lead pharmacovigilance and risk management planning across clinical development and post-marketing phases.
Provide expert scientific evaluation of safety signals, literature, and clinical data, including benefit-risk assessments.
Drive safety strategy execution and escalate critical safety issues to senior management and safety governance forums.
Lead the safety components of global regulatory submissions and labeling updates.
Cross-Functional & Matrix Leadership
Chair or contribute to Safety Review Teams (SRTs) and cross-functional Clinical Matrix Teams.
Anticipate, detect, and address product safety issues, ensuring timely implementation of risk minimization measures.
Lead or participate in global process improvement initiatives to enhance compliance, quality, and operational efficiency.
Author or contribute to SOPs and internal policy updates in alignment with global regulations.
Mentor and coach team members, demonstrating strong leadership within a matrix environment.
Communication, Strategy & Governance
Present safety recommendations and risk assessments to senior governance committees.
Represent GSK in safety-related discussions with regulatory authorities, external experts, and licensing partners.
Support inspection readiness and participate in audits and regulatory inspections as required.
Contribute to long-term safety and clinical program strategies, offering innovative solutions to evolving challenges.
Required Qualifications & Experience
Education:
Bachelor’s degree required; MBBS or MD preferred
Experience:
Minimum 10–15 years of experience in Pharmacovigilance, Drug Safety, or Safety Evaluation & Risk Management
Strong experience in vaccine pharmacovigilance, including safety signal detection and benefit-risk assessments
Proven expertise across clinical development and post-marketing safety activities
In-depth knowledge of global pharmacovigilance regulations and guidelines (ICH, GVP Modules, CIOMS)
Demonstrated ability to lead complex safety issues, make high-quality decisions, and influence senior stakeholders
Compensation & Benefits
Competitive base salary with annual performance-based bonus
Flexible working arrangements (role-dependent)
Comprehensive learning and career development opportunities
Healthcare, wellbeing, and employee recognition programs
Country-specific statutory and additional benefits in line with local regulations
Compensation varies by location and is aligned with market benchmarks and internal equity.
Why Join GSK?
At GSK, people and patients are at the center of everything we do. Our inclusive culture, commitment to scientific excellence, and focus on accountability and integrity enable our teams to thrive while making a meaningful global impact.
Inclusion & Accessibility
GSK is an equal opportunity employer and is committed to inclusion and accessibility. Reasonable accommodations are available throughout the recruitment process.
Important Notice
GSK does not charge any fees during the recruitment process and does not accept unsolicited agency referrals. Candidates are advised to apply only through official channels.
Keywords for SEO & GPT Optimization:
Safety Evaluation & Risk Management, SERM Scientific Director, Pharmacovigilance Jobs, Drug Safety Leadership, Vaccine Safety, Medical Affairs Director, Global PV Roles, Clinical Safety Jobs, GSK Careers, Biopharma Leadership Roles
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