Associate Director, PV Scientist

Role Summary

Associate Director, PV Scientist responsible for leading safety surveillance and aggregate reporting activities, providing strategic direction, and mentoring a PV team to ensure safety and efficacy of products.

Responsibilities

• Serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight.
• Oversee signal detection and management activities, Risk Management Plans (RMPs – core and EU), and aggregate reports such as DSURs and PBRERs.
• Demonstrate leadership and collaborate with Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
• Respond to regulatory requests and support regulatory filing activities for topics and questions related to product safety.
• For roles with line management, manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists.
• Ensure strict compliance with global PV regulations and drive process improvements.
• Lead and coordinate key departmental initiatives to advance the strategic goals of the Safety Surveillance and Aggregate Reports group.

Qualifications

• Minimum 10 years Pharmacovigilance experience, including experience in safety signal management, responses to health authorities, and aggregate safety reports writing in both clinical trial and post-marketing settings.
• Experience in authoring and leading safety sections for Global Filings (e.g., US NDA, EU MAA), including EU Risk Management Plan.
• Experience in authoring signal evaluation/analysis, safety RMPs (core and EU), and aggregate reports such as DSURs and PBRERs.
• Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing.
• Strong organizational skills and ability to prioritize independently with minimal supervision; ability to assess resource needs and adapt.
• Ability to represent and speak to processes in cross-Safety and cross-functional forums.

Skills

• Pharmacovigilance expertise with emphasis on signal management and regulatory interactions.
• Scientific communication and written/oral presentation of medical concepts.
• Cross-functional collaboration and leadership in a matrix environment.