Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist reports to the Senior Director of Drug Safety and leads safety surveillance activities across the product lifecycle, from early clinical studies through commercialization. Responsibilities include signal detection, aggregate report authoring, benefit-risk assessment, and regulatory safety documentation for assigned oncology programs. The role ensures compliance with global pharmacovigilance standards and supports data-driven development decisions.

Responsibilities

• Lead safety surveillance and signal detection activities for assigned oncology programs
• Author and contribute to regulatory safety documents including DSURs, PSURs, and risk assessments
• Conduct benefit-risk assessments and maintain safety data presentations across product lifecycle
• Review clinical trial protocols, informed consent forms, and investigator brochures for safety
• Collaborate with pharmacovigilance operations to develop and optimize drug safety processes

Requirements

• Advanced degree in life sciences, pharmacy, or related field
• Pharmacovigilance experience in clinical development and post-marketing surveillance
• Expertise in adverse event assessment, signal detection, and benefit-risk evaluation
• Knowledge of global regulatory requirements and pharmacovigilance standards
• Proficiency in safety report authoring (DSURs, PSURs, PBRERs)
• Strong cross-functional collaboration and scientific communication skills