The Associate Director of Pharmacovigilance will provide expert PV leadership to independently review and assess safety information from various sources. This includes evaluating medical content and leading the identification of potential safety signals at both the individual case and aggregate levels. The role involves taking the lead in safety activities and benefit-risk assessments for assigned programs, chairing Safety Surveillance Committees, and contributing significantly to Independent Data and Safety Monitoring Committees (DSMCs) meetings.

Qualifications:

• MD or equivalent required.
• Postgraduate qualification or experience in gene therapy, cell therapy clinical development, or a related specialty is preferred.
• At least 8 years of experience in pharmacovigilance.
• In-depth knowledge of pharmacovigilance processes and the ability to apply this expertise to evaluate safety concerns and minimize patient risk throughout the product lifecycle.
• Experience in the cardiovascular or rare disease is highly desirable.

Responsibilities:

• Lead safety activities and develop benefit-risk strategies for assigned programs, chairing program Safety Surveillance Committees and contributing to DSMC meetings for investigational products.
• Provide medical input and review of aggregate safety reports (PBRER, DSUR, 120-day safety updates), safety sections of clinical trial documents (such as protocols, clinical study reports, investigator brochures, informed consent forms), and regulatory submissions (clinical trial applications, marketing authorization applications).
• Serve as the medical expert in safety for assigned programs
• Prepare responses to safety-related queries from regulatory authorities as needed.