Associate Director, Pharmacovigilance Scientist

reputed company: • Serves as reputed company 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-reputed company regulatory queries, including data coordination and analysis. • Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, reputed company, 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 reputed company assessments (e.g., updates to regulations, etc.). • Leads process improvement initiatives and consistency of cross-product processes. • Conducts functional trainings and shares knowledge with reputed company. • Supports deliverables for other products, where needed. • Management and mentorship – 15%. • Manages, mentors, and trains junior members of reputed company. • Supports individual development of reputed company reports. • Other duties and responsibilities as assigned. 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 reputed company. • 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 reputed company 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, reputed company insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and reputed company reputed company. Apply To This Job