- BeOne Medicines (Emeryville, CA)
- …The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to ... signal assessment strategy and assess potential impact on the product safety profile with recommendation for action...manner. + Lead the development, update, and review of safety communication documents (eg, Dear Investigator Letter,… more
- AbbVie (North Chicago, IL)
- …to safety questions from investigator sites and IRBs regarding safety issues and queries. Post-market/ Product Surveillance Safety + Ensure ... communicate safety issues. May contribute relevant clinical safety input to new product design teams...based on the clinical study requirements. + Responds to safety questions from investigator sites and IRBs… more
- Parexel (Atlanta, GA)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP),… more
- Mount Sinai Health System (New York, NY)
- …or a commutable distance to meet onsite/hybrid requirements for this position.** The Product Manager - AI is a key leadership role responsible for defining, ... and delivering AI-driven solutions to optimize clinical effectiveness and improve patient safety across hospitals and diverse care settings. This role will lead the… more
- Sanofi Group (Cambridge, MA)
- …from health authorities, ethics committees/ IRBs, external partners + Management of product safety alerts + Ensuring the GPV's position is well ... + Provide PV and risk management expertise to internal and external customers + Safety expert for product must have an attitude of continuous learning and… more
- Sanofi Group (Morristown, NJ)
- …questions from health authorities, ethics committees, IRBs, external partners + Management of product safety alerts + Ensuring the GPE position is well ... Expert:** + Provide PV and risk management expertise to internal and external customers + Safety expert for product + Maintain knowledge of product , … more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF). * Conducts Investigational Product (IP) review and ... and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan. * Monitors data,… more
- AbbVie (Irvine, CA)
- …generate, deliver, and disseminate high-quality data supporting consumer eye care product scientific and business strategy. Responsibilities: *Serves as an in-house ... programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of… more
- Pfizer (Bothell, WA)
- …and performing proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety ... of the benefit-risk profile across Pfizer's portfolio and to advocate for patient safety from first-in-human and throughout a product 's lifecycle. The Safety… more
- Ascendis Pharma (Palo Alto, CA)
- …strategy, set priorities and lead pharmacovigilance activities for assigned products. The Program Safety Lead stewards the product safety profile and drives ... pipeline. As a key member of the Global Patient Safety Organization and cross-functional product teams, you...SUSARs, PSURs, DSURs, IND Annual Reports) + Contribute to safety sections of labeling, investigator brochures, protocols,… more