SERM Scientific Director

Role Summary

SERM Scientific Director responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.

Responsibilities

• Implement policy, processes and support the implementation of operational and strategic plans
• Ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for the further characterization, management, and communication of safety risks
• Focus on efficiency and effectiveness to meet the needs of patients and healthcare professionals. Support pharmacovigilance and benefit-risk management of the assigned portfolio of Global assets to ensure patient safety globally

Qualifications

• Required: Health Sciences/Health Care Professional degree (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D; dentists and veterinarians also accepted)
• Required: Comprehensive experience in the Pharmaceutical or Biotech industry in Drug Safety or Pharmacovigilance
• Required: Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, including clinical development and post-marketing activities
• Required: Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS) and drug development and approval processes
• Preferred: Advanced Degree
• Preferred: Experience in large matrix organizations
• Preferred: Experience in Oncology

Skills

• Expert in clinical safety and pharmacovigilance activities
• Judgment and decision-making in safety evidence generation, benefit-risk assessment, causality assessment, safety signal evaluation, and proactive risk management
• Coaching and mentorship in signal evaluation methodology and risk management and regulatory safety reports
• Strong analytical skills, medical/scientific judgment, urgency in drug safety
• Safety governance leadership and risk-reduction strategy execution
• Cross-GSK leadership in safety advisory panels and governance committees
• Ability to engage broadly within GSK and external pharmacovigilance communities

Education

• Not specified beyond the degree requirements listed in Qualifications

Additional Requirements

• None specified