Associate Director, Pharmacovigilance Scientist

Role Overview

• Serves as lead PV Scientist for assigned product(s) – 60%.
• Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentation.
• Leads and manages the planning, preparation, writing, and review of aggregate safety reports (DSURs, PADERs, PBRERs).
• Leads and manages the planning, preparation, writing, and review of risk management plans.
• Performs literature surveillance.
• Prepares materials for safety governance meetings.
• Contributes to safety-related regulatory queries, including data coordination and analysis.
• Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, ICF, DMC materials, coding reviews, CSRs, etc., as applicable).
• Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorization Applications).
• Supports team in proactively maintaining inspection readiness and serves as a subject matter expert in the event of an inspection.
• Leads strategic innovations (streamlines processes, evaluates implementation of new technology and resources, etc.).
• Conducts impact assessments (e.g., updates to regulations, etc.).
• Leads process improvement initiatives and consistency of cross-product processes.
• Conducts functional trainings and shares knowledge with the team.
• Supports deliverables for other products, where needed.
• Manages, mentors, and trains junior members of the team.
• Supports individual development of direct reports.

Requirements

• Minimum 5-6 years PV experience, including a minimum of 3-4 years in a PV Scientist or similar role.
• Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS).
• Demonstrated experience in analysis and interpretation of medical and scientific data, including experience leading signal management activities and the preparation and authoring of aggregate reports in both post-marketing and clinical trials.
• Excellent oral and written communication skills, including the ability to effectively communicate key considerations and decision points.
• Detail-oriented with ability to think critically, prioritize tasks, and function independently.
• Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations.
• Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs.
• Prior experience serving as an SME in audits and/or inspections.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.