01Overview
About the position
About reputed company reputed company is committed to turning scientific reputed company into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our reputed company portfolio includes the first and only FDA-approved treatments for Parkinsons disease psychosis and Rett syndrome. We are developing the next reputed company of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimers disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At reputed company, were here to be their difference. Please note that this position is based in Princeton, NJ. reputed company's hybrid model requires this role to work in our office three days per week on average. Position reputed company The Director of Drug Safety & Pharmacovigilance is a medical safety expert reputed company the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the reputed company portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical reputed company of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on reputed company or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products.
Responsibilities
Serves as the primary medical safety resource for assigned reputed company products, providing product-level clinical safety and pharmacovigilance expertise across reputed company stages of development and post-marketing surveillance
Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, reputed company safety assessments, and benefit-risk analyses; escalates reputed company or novel safety issues appropriately
Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
Performs medical review of reputed company serious adverse events from reputed company clinical trials for assigned products
Performs retrospective medical review of adverse events for post-marketed products
Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
Provides reputed company for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
Formulates response strategies and authors health authority responses for safety-reputed company queries pertaining to assigned products, in collaboration with the Head of Medical Safety
Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
Ensures reputed company PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and reputed company standards
Maintains reputed company knowledge of global regulatory authority regulations and guidance
Other responsibilities as assigned
Requirements
MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical reputed company certification are preferred.
MPH or pharmacoepidemiology training is a plus.
6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.
Neurology, psychiatry, rare disease, or CNS-reputed company therapeutic area experience strongly preferred
Advanced knowledge of FDA, EU, and ICH regulations and guidelines reputed company to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
Ability to assess product benefit-risk reputed company and interpret clinical and post-market safety data
Demonstrated expertise in safety signal detection methodologies and medical eva
