Safety Evaluation & Risk Management (SERM) Team Leader

Role Summary

Safety Evaluation & Risk Management (SERM) Team Leader responsible for in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets in clinical development and/or post-marketing. Leads safety governance, risk management, and communication of safety risks; supports pharmacovigilance and benefit-risk management; may lead a team of individual contributors with line management responsibilities.

Responsibilities

• Leads pharmacovigilance and risk management planning; develops strategies for evaluating issues in the clinical matrix.
• Oversees the safety component of global regulatory submissions.
• Demonstrates expert evaluation skills for literature review, clinical data synthesis, analysis, and interpretation.
• Ensures quality decision-making and creative problem resolution based on relevant information/factors.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.
• Leads safety governance by developing and executing safety strategies for products in clinical development and post-marketing settings.
• Anticipates, detects, and addresses product safety issues and ensures risk-reduction strategies are implemented.
• Facilitates safety governance/SRTs by establishing cross-functional teams to address product safety issues and ensure risk-reduction in study protocols and labeling.
• Represents Global Safety on cross-functional Clinical Matrix Teams and/or Project Teams.
• Leads cross-functional ad hoc teams to address urgent product safety issues.
• Authors/participates in updates to written standards (SOPs) to ensure compliance with policies and regulations.
• Escalates safety issues and communicates with governance bodies (GSB, CHSLC, GLC, QPPV).
• Leads presentations on recommendations or safety issues to senior staff at governance committees.
• Represents GSK in safety discussions with regulatory authorities, external consultants, and licensing partners.
• Leads cross-functional process improvement teams within GSK.
• Contributes to long-term clinical program strategies and innovative approaches to operations.
• Leads inspection readiness and supports audits/inspections as needed.

Qualifications

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Advanced experience in the Pharmaceutical or Biotech industry in Medical Affairs, Pharmacovigilance, Drug Safety, or related field.
• Experience leading and managing a team.
• Preferred: Medical Doctor (physician) or equivalent with additional relevant medical/scientific postgraduate qualifications.
• Experience with vaccines.
• Significant pharmacovigilance experience in Safety Evaluation and Risk Management across clinical development and post-marketing.
• Knowledge of international pharmacovigilance requirements (ICH, GVP modules, CIOMS) and drug development/approval processes.
• Experience in large matrix organizations; strong communication and influencing skills; ability to coach and mentor others.

Skills

• Strong medical/scientific analytical skills; literature review and data interpretation.
• Strategic thinking and risk-management expertise.
• Cross-functional collaboration and leadership in matrix environments.
• Excellent verbal and written communication; stakeholder management.
• Decision-making, change management, and adaptability.

Education

• Health Sciences or related health care professional degree required. Advanced/postgraduate qualifications preferred for certain tracks.

Additional Requirements

• Location includes multiple sites (USA MA, Waltham; Belgium-Wavre; Cambridge MA; GSK HQ; Stevenage; Upper Providence) as applicable.