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Serm Medical Director, Team Lead

Gsk Plc
GSK plc
5+ Years years
$239,250 – $398,750 per year (US)
Cambridge, United States
10 March 14, 2026
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Position Summary
The SERM Medical Director, Team Lead provides advanced medical and scientific expertise in safety evaluation and risk management for pharmaceutical products in clinical development and post-marketing phases. The role supports vaccine development programs and ensures scientifically sound review and interpretation of safety data while guiding pharmacovigilance strategies to maintain global patient safety.

The position involves identifying, evaluating, and managing safety risks associated with pharmaceutical products. It also ensures that safety concerns are appropriately escalated to senior management and governance bodies while recommending strategies for risk mitigation and communication. The role contributes to the overall benefit-risk evaluation of assigned products and supports pharmacovigilance operations across global programs.

Key Responsibilities

Lead pharmacovigilance and risk management planning for products in clinical development and post-marketing stages

Develop and implement safety evaluation strategies across global clinical programs

Review and interpret clinical data, safety signals, and scientific literature to identify potential safety risks

Lead the safety component of global regulatory submissions and support regulatory interactions

Facilitate safety governance activities and support cross-functional teams in managing product safety issues

Ensure appropriate risk reduction strategies are implemented within clinical protocols and product labeling

Represent safety functions within clinical project teams and matrix organizations

Lead or participate in cross-functional initiatives to improve regulatory compliance, data quality, and operational efficiency

Contribute to development and revision of standard operating procedures (SOPs) related to safety processes

Support inspection readiness and participate in audits and regulatory inspections

Provide mentorship and leadership within safety teams and cross-functional groups

Professional Experience Requirements

Minimum 5 years of experience in pharmacovigilance, drug safety, or safety evaluation and risk management within the pharmaceutical or biotechnology industry

Experience in signal detection, safety surveillance, and benefit-risk evaluation

Strong understanding of global pharmacovigilance regulations including ICH guidelines, GVP modules, and CIOMS standards

Experience working in cross-functional matrix organizations and leading safety governance initiatives

Preferred experience in vaccines safety, epidemiology, or clinical safety evaluation

Apply Details

Apply via the company career portal for
GSK