SERM Medical Director

Glaxosmithkline Consumer Healthcare SA; Greater London; Hybrid; GBP 60,000 - GBP 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a safety expert to lead pharmacovigilance and risk management initiatives. This role will oversee the safety evaluation of products, engage in global regulatory submissions, and collaborate across teams to address safety issues. The ideal candidate holds a medical degree with extensive experience in drug safety and risk management. This hybrid position is based in the UK, offering opportunities for professional growth while impacting patient safety.

Benefits

Collaborative work environment

Hybrid working model

Qualifications

• Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance.
• Significant pharmacovigilance experience related to Safety Evaluation and Risk Management.
• Knowledge of international pharmacovigilance requirements.

Responsibilities

• Leads Pharmacovigilance and Risk Management Planning.
• Leads safety component of global regulatory submissions.
• Facilitates safety governance and ensures risk-reduction strategies.

Skills

Pharmacovigilance

Clinical data synthesis

Analytical thinking

Cross-functional leadership

Regulatory knowledge

Education

Medical degree

Tools

Safety databases

Safety systems configuration

Job description

Site Name: UK – London – New Oxford Street
Posted Date: Jan 27 2026

Business Introduction
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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Position Summary
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or 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.

Key Responsibilities

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
• Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
• Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.

Cross-functional Matrix team leadership

• Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
• Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
• Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
• Authors/particip in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
• Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
• Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others.

Communications (verbal, written) and Influencing (internal PV Governance and External LTs)

• Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
• Leads cross-functional process improvement team within GSK. Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs. Regularly contributes innovative ideas to address new issues or to existing operations.
• Leads inspection readiness and prepared as needed to support audits/inspections.
• Excellent communication (verbal, written) and influencing (internally and externally) skills.

Basic Qualification

• Medical degree
• Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
• Experience with Signal Detection and safety surveillance
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Experience working in large matrix organizations

Preferred Qualification

• Experience leading cross-functional safety governance or Senior Review Teams.
• Experience with safety databases, safety systems configuration or validated computerized systems.
• Project or change management experience within regulated environments.
• Experience engaging with regulatory authorities or external safety working groups.
• Track record mentoring or managing scientific colleagues in safety roles.

What you will gain
You will expand your influence across global safety operations and develop skills in safety strategy, regulatory interactions and cross-functional leadership. The role gives you the chance to shape processes that protect patients and to grow your career within a global organisation committed to scientific rigour and collaboration.

Working model
This role is hybrid, based in the United Kingdom. You will be expected on site for key meetings, governance activities and team collaboration. Remote working is supported to balance focus time and effective stakeholder engagement.

How to apply
If this role speaks to you, please apply with your CV and a short note describing a safety assessment or risk management activity you led and its impact. We encourage candidates from many backgrounds to apply.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.