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Pharmacovigilance Operations Manager
1 month ago
Beacon Hill Staffing Group - Pharmacovigilance Operations Manager - Helena, Montana The contract PV Operations Manager will provide ICSR case processing and medical review oversight in collaboration with PV vendor, DSPV Safety leads, Safety Scientist, and Medical monitor to ensure timely and quality ICSR case processing from ongoing clinical trials. In collaboration with the PV Operations Senior Director, the contract PV Operations Manager will support the management of the Safety database through a PV vendor, ICSR medical review oversight, ICSR quality checks, and documentation of findings/trends, and triage of the DSPV safety mailbox with emphasis on global regulations. This individual must effectively interface cross-functionally at all levels within the organization, including but not limited to the Pharmacovigilance team, Clinical Operations team, Regulatory affairs team, Quality organization, and cross-functional teams for clinical development programs. Additionally, they will communicate effectively with external stakeholders, investigators, vendors, and Regulatory Authorities. Responsibilities include, but are not limited to: Develop medical review strategy for ICSRs for clinical trials across platforms in collaboration with PV operations, Safety surveillance team, and CRO. Provide oversight of ICSR medical review in collaboration with CRO medical reviewer and internal Safety and medical colleagues as required. Manage safety database through PV vendor. Collaborate with PV operations team and PV vendor to ensure timely and high-quality ICSRs from intake to submission. Represent DSPV in various cross-functional teams (e.g., Clinical Study Team, Medical Monitoring Meeting). Ensure that safety reports are triaged, scheduled, processed, and reported accordingly per global requirements and internal SOPs. Provide day-to-day interaction with internal vendors under the direction of DSPV Operations management as related to case processing. Collaborate with PV vendor, clinical studies vendor(s), and regulatory operations to ensure quality and compliance for safety reporting (e.g., KPI). Communicate with partner companies, vendors, and internal groups regarding processing and timely exchange of safety reports under direction of DSPV Operations Director. Support development and implementation of Safety Management Plans for study-specific workflow between the company and CRO(s). Assist in development, contribute, review, and maintain up-to-date safety case processing SOPs, forms, etc. Represent DSPV Operations in study management teams for assigned products, as needed. Assist with reconciliation of safety data with data management and business partners as applicable. About You: Experienced safety professional (RN, PharmD). Solid clinical experience from direct patient care. 7+ years of experience in drug safety and pharmacovigilance in medical review/ICSR case processing and PV operations from novel clinical development programs. Knowledge and hands-on experience of good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines for ICSR case processing including intake, medical review, and regulatory submissions. Knowledge of MedDRA dictionary and strong case processing and narrative writing skills. Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent). Strong computer skills (MS Office). Prior experience with gene therapy products or biologics and direct patient care experience as a clinician will be a plus. Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. #J-18808-Ljbffr
