- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient, ... accurate and timely reporting of adverse events, aggregate safety reports (ie PADER) and other Pharmacovigilance activities. This person will assist the LPVRP… more
- Kelly Services (South San Francisco, CA)
- …Overview:** The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for ... provide PV technical support to one or more Clinical Project Teams to ensure the successful design and implementation...good pharmacovigilance practices and current regulations within drug safety . + Working knowledge of validated… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …aggregate reports preparation, signal management and ad hoc requests. + Support drug safety systems through business administration tasks, including database ... deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing… more
- Lilly (Indianapolis, IN)
- …system change management process for PV systems. + Perform configuration of PV safety systems such as global reporting rules and conducting Product License Study ... activities. PV Data Reporting & Compliance + Provide PV and Lilly safety reports through existing/adhoc queries with high quality and accuracy through appropriate… more
- Parexel (Springfield, IL)
- …considered. + Good knowledge/understanding of medical terminology + Relevant experience in pharmacovigilance / Drug Safety / Clinical Practice **Education:** + ... labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... and/or investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Chair or… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... Patient Safety Physician - Inflammation has responsibility for the pharmacovigilance risk management activities of investigational compounds on a global level.… more
- BeOne Medicines (Emeryville, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees. ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report… more
- Organon & Co. (Jersey City, NJ)
- …submissions or renewals for the general medicines portfolio of products. + Support Drug Safety and Pharmacovigilance with activities such as review ... interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance , Chemistry, Manufacturing and Controls… more
- AbbVie (North Chicago, IL)
- …signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance , supporting all patient safety activities. Responsibilities: ... to effectively conduct safety surveillance * Conducts safety surveillance for pharmaceutical/biological/ drug -device combined products; contributes to… more
- Bayer (St. Louis, MO)
- …clinical scientist position with deep expertise in key topics in pharmacovigilance (eg drug -induced liver injury (DILI), reproductive toxicity, quantitative ... signal detection etc.), oncology drug development and clinical medicine, including methods to assess...applies processes across assigned team. + Technical expertise in pharmacovigilance and clinical safety . + Excellent analytical… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …continuity. **Basic Qualifications:** + MD or equivalent with 4+ years of experience in drug safety / pharmacovigilance , with a focus on clinical trials and ... cross-functional collaboration **Preferred** **Qualifications** **:** + 5+ years of experience in drug safety / pharmacovigilance , with a focus on clinical… more
- Sanofi Group (Cambridge, MA)
- …knowledge of product, product environment, and recent literature + Maintain expertise in drug safety and PV, and understanding of international safety ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution… more
- Sanofi Group (Cambridge, MA)
- …and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of ... **Job Title:** Global Safety Officer, I&I **Location:** Morristown, NJ Cambridge, MA...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Sumitomo Pharma (Providence, RI)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... Management Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional… more
- Lilly (Indianapolis, IN)
- …strong publication record. + Proficiency in data analysis and reporting. + Experience in drug safety is not required. **Other Information** + This position is ... industry, government, and academia. The candidate will develop key skills in pharmacovigilance and safety science (particularly with respect to novel… more
- ThermoFisher Scientific (Greenville, NC)
- …background check, which includes a drug screening. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in ... regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific… more
- Sanofi Group (Morristown, NJ)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research &… more
- Merck (North Wales, PA)
- …Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines ... Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… more
- Cytel (Columbus, OH)
- …expert and collaborates cross-functionally with clinical operations, data management, safety / pharmacovigilance , biostatistics, and medical writing teams to ... coding of medical terms using standardized dictionaries (eg, MedDRA, WHO Drug ). This individual brings advanced knowledge of medical terminology, clinical trial… more