- Takeda Pharmaceuticals (Boston, MA)
- …quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance ) bring their expertise to our ... global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Statistics and Quantitative… more
- Nestle (Bohemia, NY)
- …of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering automation, regulatory ... compliance, quality management and compliance, medical information, or clinical trials applications; and, + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations +… more
- Sumitomo Pharma (Augusta, ME)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance to implement discovery and development ... responsibility, this job has oversight for the design and execution of nonclinical safety programs to support the development of drug candidates from discovery to… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... (FDA, Health Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements. + Maintains thorough… 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
- ICON Clinical Research (Blue Bell, PA)
- … teams to assess Serious Adverse Events and contribute to the development of Safety Management Plans, Pharmacovigilance Plans, and Risk Management Plans. + Serve ... as a trusted medical advisor to clients throughout the duration of each project. **Key Requirements:** + A medical degree with license to practice and board certification in either Pulmonology or Internal Medicine + Experience in Pulmonology is essential,… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance , Translational Medicine, Regulatory Affairs, ... Biostatistics, Clinical Study Units, Medical Affairs, and CROs to optimize study design and execution. **Study Document Development** + Author, review, and validate study-related documents including trial protocols, informed consent forms, case report forms,… more
- Ascendis Pharma (Palo Alto, CA)
- …Safety Database. + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure ... the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head,...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- AbbVie (North Chicago, IL)
- …. Job Description Purpose: This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) ... colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide. The PST is a… more