- Merck & Co. (Rahway, NJ)
- …Head and CRD as needed.Works in partnership internally with GCTO country operations , finance, regulatory affairs, pharmacovigilance , legal and regional ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and External Vendors for the data services they provide to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Merck & Co. (North Wales, PA)
- …other type of agreements related to clinical research.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and ... level of collaboration and interaction with the GCTO Country Operations /Research Division Functional area and act as a liaison...of relevant experience in the pharmaceutical industry or an Associate 's Degree with a minimum of 5 years of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled… more
- Boehringer Ingelheim (Athens, GA)
- **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance (PV) team to ensure compliance with all regulations and laws worldwide on ... Pharmacovigilance (including but not limited to FDA 21 CFR,...**Duties & Responsibilities** + Together with Head of PV Operations , establish and maintain scientifically valid ongoing safety surveillance… more
- Amgen (Washington, DC)
- …pharmacovigilance related experience Or Bachelor's degree and 8 years of safety/ pharmacovigilance related experience Or Associate 's degree and 10 years of ... patients worldwide. It's time for a career you can be proud of. ** Pharmacovigilance Scientist, Senior Manager** **Live** **What you will do** Let's do this. Let's… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …according to prevailing standards + Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal ... and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance … more
- Taiho Oncology (Princeton, NJ)
- …with team members. + Maintain training and oversight to clinical operations / pharmacovigilance vendors supporting pharmacovigilance activities, as needed. ... Associate Director, PV Sciences Pleasanton, CA, USA *... Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment… more
- Merck (Columbus, OH)
- …team (eg Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory ... **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety...trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality … more
- Lilly (Indianapolis, IN)
- …may impact a positive benefit-risk balance for a given product. The Associate Director Pharmacoepidemiology Study Operations (AD Ops)is responsible for providing ... support specific studies + Liaise between PE scientists and Research and Development Operations (RD Ops) /Procurement/ Quality in the contracting of PE studies to… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director, External Research, Scientific Affairs provides strong subject matter expertise, operational oversight and process requirement ... continuous improvement and customer experience mentality to refine processes and operations that support an evolving healthcare market. + Maintains expert knowledge… more
- Bristol Myers Squibb (Minneapolis, MN)
- …investigators in their geography + Ensures active collaboration with Region Clinical Operations partners and actively engages in issue escalation and resolution + ... Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing… more
- Merck (Columbus, OH)
- …CRD as needed. + Works in partnership internally with GCTO country operations , finance, regulatory affairs, pharmacovigilance , legal and regional operations ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- ThermoFisher Scientific (Wilmington, NC)
- …(comparable to 1-2 years) in the industry. + Direct experience in safety/ Pharmacovigilance (comparable to 2 years). _In some cases an equivalency, consisting of ... EMA and GCP) + Working knowledge of biostatistics, data management, and clinical operations procedures + Ability to act as a mentor/trainer to other staff within… more
- ThermoFisher Scientific (Wilmington, NC)
- …to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance (comparable to 2 years). _Additional experience required for Sr Med Director ... EMA and GCP) + Working knowledge of biostatistics, data management, and clinical operations procedures + Ability to act as a mentor/trainer to other staff within… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as chairperson the output of cross-functional evidence team (Clinical Operations , Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, Medical ... Affairs, Market Access, Epidemiology, RWE etc) assuming clinical development & budget responsibility for designated programs, and presents project related proposals and updates to internal governance committees, as well as external bodies (eg, Health… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research,… more
