Associate Director, Drug Safety and Pharmacovigilance Operations

At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. As the Associate Director, Drug Safety and Pharmacovigilance Operations, you will play a critical role in supporting PV across all clinical development programs.

Requirements

• Degree in Life Sciences, Pharmacy, Nursing or related field
• 8+ years of experience in PV in Biotech, Pharma, or a CRO
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER)
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance
• Effective collaboration and interpersonal skills
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance
• Excellent decision-making and analytical skills

Benefits

• Unlimited PTO
• Lifestyle spending account
• Commuting reimbursement