Safety Evaluation & Risk Management (SERM) Team Leader

Role Summary

Safety Evaluation & Risk Management (SERM) Team Leader. Provides 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. Supports pharmacovigilance and benefit-risk management of the assigned portfolio to ensure patient safety worldwide. May lead a team of individual contributors with line management responsibilities.

Responsibilities

• Leads pharmacovigilance and risk management planning, developing strategies for evaluating issues in the clinical matrix.
• Oversees the safety component of global regulatory submissions.
• Demonstrates expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis, and interpretation.
• Ensures quality decision-making and creative problem resolution based on assessment of all relevant information.
• 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 appropriately.
• Facilitates safety governance/SRTs by establishing cross-functional teams to address product safety issues and ensure risk-reduction in protocols and labeling.
• Represents Global Safety on cross-functional Clinical Matrix Teams/Project Teams.
• Leads cross-functional ad hoc teams to address urgent safety issues.
• Authors/participates in updates to written standards to ensure policies and regulations are adhered to correctly.
• Escalates safety matters and communicates with senior governance bodies.
• Leads presentations on recommendations or safety issues to senior staff and participates in safety-related discussions with regulatory authorities and partners.
• Leads cross-functional process improvement teams and contributes to long-term clinical program strategies.
• Regularly contributes innovative ideas to address new issues or improve operations; supports inspections and audits as needed.

Qualifications

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

Skills

• Strong medical/scientific evaluation and data interpretation skills.
• Strategic thinking for safety risk management and governance.
• Cross-functional collaboration and leadership in matrix environments.
• Excellent verbal and written communication; stakeholder management.
• Change management, decision-making, and problem-solving abilities.

Education

• Health Sciences/Health Care Professional degree required (as listed above).