Associate Director, Pharmacovigilance

Rocket Pharmaceuticals • Cranbury Township, NJ

419d • $168,000 - $220,000

About The Position

The Associate Director of Pharmacovigilance at Rocket Pharmaceuticals is responsible for leading safety activities and benefit-risk strategies for assigned programs. This role involves independent medical and scientific review of safety information, chairing safety committees, and contributing to regulatory filings. The position requires strong leadership skills and the ability to foster collaboration across various teams to ensure patient safety and compliance with regulatory standards.

Requirements

• MD/equivalent required.
• 8 or more years of pharmacovigilance experience.
• Expert knowledge of pharmacovigilance and safety assessment.
• Excellent verbal and written communication skills.
• Demonstrated leadership skills and process/infrastructure building experience.
• Strong scientific analytical reasoning skills.
• Proven track record of effective vendor oversight.

Nice To Haves

• Postgraduate qualification or experience in gene therapy/cell therapy clinical development or related specialty.
• Proficient ability to leverage available tools to investigate safety concerns.
• Understanding of regulatory requirements for safety assessment and action.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned programs by chairing the program Safety Surveillance Committee(s).
• Provide medical input and review aggregate safety reports and clinical trial documents.
• Serve as a safety medical expert to evaluate adverse events and provide company causality assessments.
• Prepare and review answers to safety queries from regulatory authorities.
• Lead safety strategy preparation for pre-submission and Advisory Committee meetings.
• Provide PV expertise regarding potential post-approval safety commitments.
• Represent PV in clinical development projects and provide expert medical guidance on safety matters.
• Lead signal management processes and conduct medical evaluations of safety-related information.
• Provide leadership oversight of safety vendors and back-up for the Head of PV.
• Participate in continuous improvement activities for the PV department.

Benefits

• Competitive compensation package
• Generous 401K match
• Stock options
• Excellent health benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree