Vice President, Global Pharmacovigilance

Sarepta is seeking a Vice President, Global Pharmacovigilance to lead the implementation and execution of pharmacovigilance and risk management activities. The ideal candidate will have a strong background in drug safety, regulatory compliance, and leadership experience. The role will involve overseeing pharmacovigilance and risk management activities, designing and conducting ongoing safety surveillance, and providing medical expert safety review input into critical documents. The position requires a strong understanding of FDA safety regulations, ICH Guidelines, and EU GVP, as well as experience with relational database applications and clinical safety assessments. The successful candidate will have a dynamic leadership style, excellent communication skills, and the ability to work in a fast-paced environment.

Requirements

• M.D. degree in health sciences is preferred
• Clinical expertise in rare disease preferred
• Minimum of 10+ years of progressive experience in Drug Safety in a biotechnology or pharmaceutical company required
• Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents
• Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process
• Expert knowledge of relational database applications (including ARGUS, ARISg, or other safety database)
• Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
• Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
• Effective team player, fosters collaboration within and across functional areas
• Sound strategic evaluation, analysis, and decision-making skills
• Ability to work in a dynamic, fast paced environment
• Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers