Safety Evaluation & Risk Management (SERM) Team Leader

Role Summary

Safety Evaluation & Risk Management (SERM) Team Leader.

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 supporting and conflicting 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 (e.g., product incidents) and ensures risk-reduction strategies are implemented appropriately.
• Facilitates safety governance/SRTs by establishing and operating cross-functional teams to address product safety issues and ensure risk-reduction strategies are implemented in clinical study protocols and/or product labeling.
• 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.
• Authors/participates in updates to written standards (e.g., SOPs) to ensure policies and regulations are adhered to correctly and consistently.
• Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
• Leads presentations on recommendations or safety issues to senior staff members at GSK Senior Governance Committees.
• Represents GSK and contributes to safety-related discussions at meetings with regulatory authorities, external consultants, and licensing partners.
• Leads cross-functional process improvement teams within GSK.
• Contributes to the development of long-term strategies for clinical programs.
• Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
• Leads inspection readiness and supports audits/inspections 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 working in Medical Affairs, Pharmacovigilance, Drug Safety, or a related field.
• Required: Experience leading and managing a team.
• Preferred: Medical Doctor (physician) or equivalent with additional relevant medical or scientific post-graduate qualifications.
• Preferred: Experience with Vaccines.
• Preferred: Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
• Preferred: Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Preferred: Experience working in large matrix organizations.
• Preferred: Strong communication (verbal and written) and influencing skills internally and externally.
• Preferred: Ability to coach and mentor others.

Skills

• Expert evaluation and analytical skills for literature review and data interpretation.
• Strategic safety governance and risk-management planning.
• Cross-functional leadership and stakeholder management.
• Communication and influencing skills.

Education

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

Additional Requirements

• Location: USA - Massachusetts - Waltham; Belgium - Wavre; Cambridge MA; GSK HQ; Stevenage; Upper Providence (as applicable).