- BeOne Medicines (San Mateo, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report ... medical field or biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist. + MD (or internationally recognized equivalent) plus… more
- Parexel (Bismarck, ND)
- …of Medical Monitoring and study design/execution, preferred - Good knowledge of the drug development process including drug safety , preferred - Excellent ... clients in the journey of getting new and innovative drug treatments into the hands of those who need.../ Medical Director are to: - Provide medical and safety monitoring for assigned projects - Provide medical expertise… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Manager , Pharmacovigilance Department: Pharmacovigilance Location: Elmwood Park, NJ START YOUR APPLICATION ... in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient,… 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 ... like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …the Specialist, Pharmacovigilance is focused on meeting ConnectiveRx's obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical ... potential sources of safety information under the guidance of the Manager , Pharmacovigilance . Sources may include recorded calls, claims, faxes, text… more
- ThermoFisher Scientific (Cambridge, MA)
- …communities depend on - now and in the future. Discover Impactful Work: The Associate Manager Safety Data and PV Systems will lead deliverables for GPS (Global ... Safety application to ensure reliable and compliant drug safety case processing. + Assist in...associated business intelligence platforms. + Collaborate closely with the pharmacovigilance , clinical, and regulatory teams to ensure safety… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. Global Safety Senior Manager , Rare Disease **What you will do** Let's do this. ... this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for...guidance of GSO. + Support activities related to new drug applications and other regulatory filings: Assist GSO in… more
- Takeda Pharmaceuticals (Boston, MA)
- …of data visualization tools such as Tableau/Spotfire is preferred + Knowledge of drug safety regulations (eg, ICH, FDA, EMA guidelines) and pharmacovigilance ... that will inspire you and empower you to shine? Join us as a Senior Manager , Global Safety Database Configuration in our Cambridge, MA office. At Takeda, we… more
- Sumitomo Pharma (Providence, RI)
- …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
- IQVIA (New York, NY)
- ** Manager , Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to ... clients are looking for insight and evidence on the safety , efficacy, and cost-effectiveness of their products across a...solutions as well as exceptional professional development. As a Manager , you will have the opportunity to directly address… more
- Bristol Myers Squibb (San Diego, CA)
- …(eg, INDs, CTAs, NDAs, MAAs, briefing documents) + Patient narratives and safety summaries + Ensure all documents comply with regulatory guidelines (ICH, FDA, ... Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance , clinical operations and other departments) for source data,… 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
- AbbVie (North Chicago, IL)
- …and the review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical ... teams and internal stakeholders. + Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the… more
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