Job Description

Ionis Pharmaceuticals, a pioneer in RNA-targeted medicines, is seeking a Medical Director - Drug Safety Physician to collaborate with the Product Lead or Head of Drug Safety. This role is responsible for the clinical safety strategy for assigned drug projects and products, providing drug safety expertise and guidance to Clinical Development, the Safety Oversight Committee (SOC), and the Clinical Project Teams. The ideal candidate will have a medical degree, at least 5 years of clinical experience post-registration, and at least 5 years of Drug Development/Patient Safety experience. They should have a high level of medical competence, with the ability to balance this with industry standards to achieve business goals. Key responsibilities include: Performs individual case report assessment and determines regulatory reporting responsibilities as required Provides medical review of case narratives for medical content, accuracy, and signal detection Interpret aggregate safety data for periodic reports and evaluating for potential new signals Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs Requirements include: Medical degree (e.g., MD, MBBS) At least 5 years of clinical experience post-registration At least 5 years of Drug Development/Patient Safety experience A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements Ionis offers an excellent benefits package and a pay scale of $235,553 to $314,252 for this position. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. #J-18808-Ljbffr Ionis Pharmaceuticals Inc

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