SERM Medical Director

Role Summary

Provides in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets across clinical development and post-marketing settings. Ensures scientifically sound review and interpretation of data and management of safety issues, escalating safety concerns identified through the safety review process to senior management and safety governance as appropriate. Supports pharmacovigilance and benefit-risk management of the assigned portfolio to ensure patient safety globally.

Hybrid role based in the United Kingdom.

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• 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.

• 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 (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
• Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM 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 GS 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 Work streams 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 (e.g., GSB, CHSLC, GLC, QPPV).
• 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.

• 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 internal and external environments when addressing safety issues and changes to SERM processes or business improvements. Contributes to long-term strategy for clinical programs and offers innovative ideas to address new issues.
• Leads inspection readiness and is prepared to support audits/inspections.
• Excellent communication (verbal, written) and influencing (internal and external) skills.

• Required:
  
  Medical degree
• Required:
  
  Completion of a formal postgraduate clinical training, clinical residency or specialty training
• Required:
  
  Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
• Required:
  
  Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
• Required:
  
  Experience with Signal Detection and safety surveillance
• Required:
  
  Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes
• Required:
  
  Experience working in large matrix organizations
• Preferred:
  Experience leading cross-functional safety governance or Senior Review Teams
• Preferred:
  Immunology SERM background
• Preferred:
  Experience with safety databases, safety systems configuration or validated computerized systems
• Preferred:
  Project or change management experience within regulated environments
• Preferred:
  Experience engaging with regulatory authorities or external safety working groups
• Preferred:
  Track record mentoring or managing scientific colleagues in safety roles
• Preferred:
  Completion of advanced specialty training, fellowship or country-equivalent…