- 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 ... deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing… 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
- 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 ... Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters...+ Prepares and presents safety information (ie safety graphs, tables, and reports) to project … more
- Lilly (Indianapolis, IN)
- …fosters inclusion and innovation. + Develop staff who demonstrateexpertise in drug development, therapeutic area science, project management and cross-functional ... This role plays a critical role in ensuring the safety and efficacy of our products while also maximizing...that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance . **6) Understand and… 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
- Boehringer Ingelheim (Ridgefield, CT)
- …antibody-based biotherapeutics, viral, and gene therapies. As the primary interface between global project teams and Nonclinical Drug Safety , the incumbent ... has oversight for the design and execution of nonclinical safety programs to support the development of drug...stages to support asset progression through development; pro-actively manage safety liabilities. + Deliver updates to Project … 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
- AbbVie (North Chicago, IL)
- …safety activities + Understanding of tools, standards and approaches used to evaluate drug safety + Exposure to medical and scientific writing, with ability ... This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and...by providing strategic management and quality authoring of PST Safety Deliverables. Responsibilities: + Demonstrates advanced project … more
- Lilly (Indianapolis, IN)
- …and efficient drug development, and ensures high-quality medical evaluation of safety data + Responsible for the oversight and actions related to regulatory ... + Receptive, engaging, and impactful contributor + Clinical development or pharmacovigilance experience preferred + Knowledge of drug development process… more
- Sumitomo Pharma (Madison, WI)
- …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
- 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 (Morristown, NJ)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- AbbVie (South San Francisco, CA)
- … safety . + Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics discipline (eg, ASA, PhUSE, DIA, etc.), depending on ... part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product ...individual interests. + Responsible for project and resource management within SSG for therapeutic area(s)… more
- Lilly (Indianapolis, IN)
- …strong research and communication skills, to contribute to an impactful research project within the Global Patient Safety (GPS) Pharmacoepidemiology (PE) group. ... GPS are committed to collecting, monitoring, evaluating, and communicating high-quality safety information through the science of pharmacovigilance . The purpose… 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
- 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 ... regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific… more
- Astellas Pharma (Cambridge, MA)
- …with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of ... specialty publications. -Play a strategic lead role in collaboration with Pharmacovigilance /Medical Safety to ensure optimal standards, processing, collection,… more
- IQVIA (Durham, NC)
- …involvement on assigned trials. Serve as a medical expert during project delivery lifecycle. Provide therapeutic and medical expertise to business development ... on assigned projects. + Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects. + Provides… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety , Clinical Sciences, Outcomes, Digital Health, Pharmaceutical ... clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and… more
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