Associate Director, Pharmacovigilance Scientist

Key Responsibilities

• Serves as lead PV Scientist for assigned product(s) – 60%
• Covers 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
• Other functional and cross-functional initiatives – 25%
• 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
• Management and mentorship – 15%
• Manages, mentors, and trains junior members of the team
• Supports individual development of direct reports

Qualifications

• 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 review 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

Preferred Capabilities

• Demonstrated experience in various therapeutic areas (e.g., oncology, CNS, etc.)
• Expert proficiency with pharmacovigilance databases and relevant coding dictionaries
• Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems

Additional Information

• 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