- 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)
- …a scientific and operationally capable workforce skilled and knowledgeable in pharmacovigilance and signal management including safety surveillance, signal ... fosters inclusion and innovation. + Develop staff who demonstrateexpertise in drug development, therapeutic area science, project management and cross-functional… 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
- BeOne Medicines (San Mateo, 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
- 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
- Sanofi Group (Waltham, MA)
- …+ Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs) + May represent Sanofi ... **Job Title:** Statistical Project Leader, Deputy Director, Global Biostatistics Sciences **Location**...of medicine? The race is on to speed up drug discovery and development to find answers for patients… 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
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