- Rhythm Pharmaceuticals (Boston, MA)
- …credentials will be considered if PV experience can be demonstrated. + 1-2 years of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA, ICH, EU ... you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of...Regulations and Requirements for Pharmacovigilance required. + Solid understanding of cross-functional … more
- Gilead Sciences, Inc. (Foster City, CA)
- …or life sciences (MD, PharmD, PhD preferred). * 10+ years of experience in pharmacovigilance , drug safety , or related regulatory roles in the ... and help create more tomorrows. **Job Description** The **Head of Safety and Pharmacovigilance - Cell Therapy** leads a specialized and expanding global team… more
- System One (Plainsboro, NJ)
- …an experienced, detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal ... Title: Global Drug Safety and PV Compliance Associate Location: Must be local for hybrid schedule in Princeton area Rate: Up to $42/hour (dependent on… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …within the organization to include but not limit to, Operations, Quality Control, Drug Safety , Pharmacovigilance , DEA and Quality Assurance and Quality ... + Independently works in Caliber Assure-iq and coordinates tasks with QA, QC and Drug Safety in support of investigation actions as needed, and in accordance… more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
- Astrix Technology (Monmouth County, NJ)
- …with a focus on pharmacovigilance or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with ... SOPs, and quality standards. + Collaborate with cross-functional teams including drug safety , regulatory affairs, clinical development, and biostatistics. +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …aggregate reports preparation, signal management and ad hoc requests. + Support drug safety systems through business administration tasks, including database ... like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US (FDA regulatory agencies),participate in ... **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's… more
- Nestle (Bohemia, NY)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications; and, + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements,… more
- Merck (Rahway, NJ)
- …Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Management Process, Pharmaceutical Regulatory Compliance, Pharmacovigilance , ... **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case review/approval… more