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Overview
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SERM Scientific Director
role at
GSK .Site Name:
UK – London – New Oxford Street, Stevenage, Warsaw Rzymowskiego 53Posted Date:
Sep 5 2025Job PurposeThis position supports the HIV Therapeutic Area.The role is responsible to:
Provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
Ensure 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.
Lead the safety components of global regulatory submissions (e.g. Module 2.7.4, ISS, RMPs, safety sections of labelling documents).
Key Responsibilities
Scientific/Medical Knowledge PV Expertise
Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
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 and ensures that risk-reduction strategies are implemented appropriately.
Facilitates safety governance/Safety Review Teams in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams 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 Global Safety 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/participates 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 to senior management and governance committees.
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. Interacts with confidence, credibility, and influence at all levels of the organization and represents GSK in safety discussions with regulatory authorities, outside consultants and licensing partners.
Leads cross-functional process improvement teams within GSK. Considers safety issues and changes to SERM processes or business improvements and contributes to the development of long-term strategy for clinical programs.
Leads inspection readiness and is prepared to support audits/inspections.
Excellent communication and influencing skills.
Why you?Basic Qualifications
Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D; Dentists and Veterinarians are also accepted). Advanced degree preferred.
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
Prior experience in the HIV therapy area and with global regulatory submissions is desirable but not essential
Why GSK?Uniting science, technology and talent to get ahead of disease together. We are a global biopharma company focused on four therapeutic areas, including HIV, with a culture of ambition for patients and accountability for impact. We are an Equal Opportunity Employer and support an agile working culture.
We are committed to equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status. If you require adjustments to our process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391. Details available on our UK Recruitment FAQ guide.
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Negotiable