Executive Medical Director, Pharmacovigilance

Role Summary

Executive Medical Director, Pharmacovigilance leads safety physicians and safety scientists in the Safety Team within Signal Evaluation & Risk Management (SERM) and oversees clinical safety, pharmacovigilance and risk management for Sarepta Therapeutics’ investigational and marketed products. The role sits in Global Pharmacovigilance & Risk Management (GPVRM) and operates in a matrix environment, collaborating with Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.

Responsibilities

• Represents GPVRM in clinical development projects, providing expert medical guidance on safety matters for investigational products; communicates or produces safety alerts/signals, development risk management plans, reference safety information and safety evaluations of emergent safety issues.
• Provides medical safety oversight in clinical trials; participates in protocol development, specifically the collection and monitoring of safety data in interventional and observational studies, medical review of adverse events/SAEs and evaluation of safety data and statistical analysis planning and reporting of study data.
• Contributes to preparation and review of periodic safety reports (DSUR, EAP Reports).
• Contributes to activities of IDMCs, DSMBs and safety events adjudication committees.
• Contributes to analysis of safety data from on-going and completed studies and their representation in clinical study reports.
• Provides leadership for IB section “Summary of Data and Guidance for the Investigator” (DCDS) and other safety sections.
• Provides leadership on clinical safety content of country marketing applications e.g. NDA/MAA Clinical Safety Summary and REMS/Risk Management Plan.
• Performs medical review oversight for individual case safety reports (ICSRs) from post-marketing sources.
• Leads product risk management strategy and facilitates production and maintenance of risk management plans.
• Participates in the signal management system with regular review of safety data for assigned products and detection and evaluation of new safety signals.
• Provides medical input to design and maintenance of REMS programs, monitoring of REMS goals and provision of REMS Assessment Reports.
• Leads benefit-risk discussions at the safety governance committees and implementation of risk minimization actions.
• Conducts medical evaluation of relevant safety-related information from toxicology, non-clinical studies, as well as product quality complaints, as needed.
• Contributes to preparation and review of periodic safety reports (FDA Enhanced PV Plan Report, PBRER).
• Provides leadership for the safety physicians and safety scientists in the SERM group.
• Participates in leadership oversight of safety vendors.
• Participates in continuous improvement activities of self as well as for GPVRM department including systems design and quality management activities.
• Contributes to development of the GPVRM department via involvement in recruiting/coaching talent and fiscal management.

Qualifications

• Preferred: M.D./D.O with solid knowledge and clinical practice experience with more than 10 years of professional experience.
• Required: Clinical Development experience.
• Required: Competent in safety reviews of clinical safety data/documents including AEs/SAEs, IBs, protocols, clinical study reports and informed consent documents and safety submissions (CTD clinical safety summary).
• Required: Competent in safety reviews of postmarketing safety documents including spontaneous reports and other individual case safety reports (ICSRs), periodic safety reports, risk management plans, company core data sheet.
• Required: Knowledge of GVP, GCP, ICH guidance and safety regulations.
• Required: Ability to communicate and collaborate effectively in a matrix environment.
• Required: Excellent written and oral communication skills.
• Required: Good judgment and decision-making skills, including identification and communication of relevant safety-related issues or concerns to GPVRM in an appropriate and timely manner.
• Required: Ability to multi-task.
• Required: Close attention to detail.

Additional Requirements

• Hybrid role; on-site work at Sarepta facilities in the United States and/or attend Company-sponsored in-person events from time to time.