- Monster (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
- 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
- Sumitomo Pharma (Augusta, ME)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- AbbVie (North Chicago, IL)
- …+ Advanced degree required (MD, PharmD, PhD) with 8-10 years of experience in Pharmacovigilance and Drug Safety - in industry/academia and comprehensive ... pharmacists, healthcare professionals responsible for signal detection, surveillance, medical safety review, and Pharmacovigilance (PV) leads across various… more
- Sumitomo Pharma (Madison, WI)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Proven track record of leadership and strategic management, team development in pharmacovigilance . + Strong understanding of drug development processes and ... President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance… more
- Lilly (Indianapolis, IN)
- …talent base that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance . **6) Understand and Support of ... This role plays a critical role in ensuring the safety and efficacy of our products while also maximizing...or nursing. + 10+ years' experience in pharmaceutical medicine, pharmacovigilance , or drug development. + Demonstrated effective… more
- Ascendis Pharma (Palo Alto, CA)
- …direction of Head of GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. ... . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate...process definition, monitoring and other roles as required by drug safety to perform the drug… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Amgen (Thousand Oaks, CA)
- …scientific and medical data in verbal and written format; 8. Utilizing software-based drug safety systems such as Argus and Rave; and 9. Researching ... Join us and transform the lives of patients while transforming your career. **Director Global Safety ** **What you will do and what we expect of you** Let's do this.… more
- US Tech Solutions (IL)
- …adverse event and product quality complaint information and complete in-take of Pharmacovigilance safety and product complaint reports in Systems. + Supporting ... assisting internal and external customers in collecting + information for product safety reports, products complaints related to products. + Supporting vendor case… more
