- Monster (Plainsboro, NJ)
- …detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess ... Title: Global Drug Safety and PV Compliance Associate Location: Must be...governance, inspection readiness, and cross-functional collaboration across our global safety network. Key Responsibilities Inspection & Audit Readiness -… more
- Monster (Bernards, NJ)
- …in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance Must have proficiency in ICH GCP Guidelines, US ... and employees Expertise working within early development through Phase III and Pharmacovigilance studies preferred Travel: Must have the ability to travel up to… more
- Monster (Bernards, NJ)
- …and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best ... contact and support all signal management activities. They will lead the safety signal governance and develop, or update associated policies, charter and procedures,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Kite and help create more tomorrows. **Job Description** The **Head of Safety and Pharmacovigilance - Cell Therapy** leads a specialized and expanding ... for setting the strategic direction, governance, and operational execution of safety and pharmacovigilance activities for both investigational and marketed… more
- Rhythm Pharmaceuticals (Boston, MA)
- …As a PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our ... and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across programs. + Assists in reconciliation… more
- Ascendis Pharma (Palo Alto, CA)
- …issues are identified. . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all ... Pharmacovigilance Department direction, standards, and processes for supporting safety monitoring activities. . Collaborates closely with the Medical Assessment… more
- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance medical monitoring (comparable to 2 years). _In some cases an ... analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (eg PBRER, PSUR, DSUR) as well as other client deliverables… more
- Sanofi Group (Morristown, NJ)
- …Your skills could be critical in helping our teams accelerate progress. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety ... group of process, method and technology experts dedicated to supporting Global Safety Officer (GSO) and Pharmacovigilance Scientists (PVS) monitoring of product… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …organization to include but not limit to, Operations, Quality Control, Drug Safety , Pharmacovigilance , DEA and Quality Assurance and Quality Management. ... record (manufacturing and/or packaging). Other key responsibilities include, support to Pharmacovigilance group for of Adverse Events as needed, identification of… more
- Takeda Pharmaceuticals (Boston, MA)
- …a core member of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, ... Description** **About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical … more
- Takeda Pharmaceuticals (Boston, MA)
- …+ At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. + At least 3 ... **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Takeda Pharmaceuticals (Boston, MA)
- …in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and ... **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes… more
- ThermoFisher Scientific (Wilmington, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs ... to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) + Experience preference towards individuals with… more
- Sanofi Group (Morristown, NJ)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups.… more
- Astrix Technology (Monmouth County, NJ)
- …and on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports ... or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with safety databases, literature… more
- System One (Plainsboro, NJ)
- …detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess ... Title: Global Drug Safety and PV Compliance Associate Location: Must be...governance, inspection readiness, and cross-functional collaboration across our global safety network. Key Responsibilities Inspection & Audit Readiness -… more
- AbbVie (North Chicago, IL)
- …pharmacists, healthcare professionals responsible for signal detection, surveillance, medical safety review, and Pharmacovigilance (PV) leads across various ... (MD, PharmD, PhD) with 8-10 years of experience in Pharmacovigilance and Drug Safety - in industry/academia and comprehensive expertise in product lifecycle… more
- AbbVie (Irvine, CA)
- …signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans + Apply current… more
- AbbVie (North Chicago, IL)
- …and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: * ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure ... high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety … more
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