- Amgen (Washington, DC)
- …million 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 ... the remit of role and responsibility + Processes and regulations for pharmacovigilance and risk management + Drug development and lifecycle management + Safety… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …PV Standard Operating Procedures, Work Instructions and Guidance. + Liaise with Global Pharmacovigilance personnel. + Support strategy and project plan for the ... Job Title Pharmacovigilance Intern Requisition JR000014011 Pharmacovigilance Intern...inter-departmental teams representing PV as determined necessary by the Manager , Post-Market Surveillance. Responsibilities + Assist the SpecGx LLC… more
- Abbott (Alameda, CA)
- …way people monitor their glucose levels with our new sensing technology. As the Project Manager , Market Insights you will provide global market insights on the ... end to end primary market research projects including identification of project objectives, research design, vendor selection and oversight, data analysis, insight… more
- BeiGene (Emeryville, CA)
- …+ Assist with integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in ... signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions._… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …The Manager , Drug Safety Aggregate Reports will function as the overall project manager for the development and finalization of assigned key safety documents ... **Responsibilities** + Creates and maintains the DSUR, PBRER and RMP development project schedules in compliance with global procedures and assigns deliverables to… more
- BeiGene (San Mateo, CA)
- …+ Contribute to integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Any other tasks assigned by manager to assist in ... signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions._… more
- AbbVie (North Chicago, IL)
- …reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety, Epidemiology & R&D Quality Assurance ( PSEQ) organization's ... and operational leadership oversight of the PST model. As an Epidemiology Study Operations Manager within the Office of the PST, you will support and partner with… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Administration: + Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing ... compliance with SDEA requirements + Supports development and maintenance of Pharmacovigilance System Master File (PSMF). Ensures accuracy and completeness of data… more
- Johns Hopkins University (Baltimore, MD)
- …Navigators. + Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns; make use of ... + Serve a critical role as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Marketed Product R&D support & Leadership** + Partner with R&D Marketed Product Project Manager to coordinate R&D function support for assigned products within ... and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance , global development operations and project management) to set… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …databases required by MTDA Drug Safety projects. Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design and ... closes with other functional groups such as medical safety evaluation team, pharmacovigilance operation, case processing, quality, and compliance team to collect the… more
- Novo Nordisk (Plainsboro, NJ)
- …through execution of data analytics and market research with customers. The CI&A manager will work and collaborate with multiple levels of management and cross ... Intelligence team, US and Global Market Research Functional team, shares project experience and best practices. Collaborates and contributes to overall activity… more
- Pfizer (Tampa, FL)
- **Role Summary** The Audit Manager , Research, Development and Supply will be part of Pfizer Corporate Audit's internal team that provides "third line of defense" ... Chain to plan and execute best in class audit assurance. The Audit Manager is responsible for identifying risks in specific business areas and conducting independent… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of Safety Statistical Programming is a strategic role in the emerging ... of integrated clinical safety data for multiple compounds and indications. The Manager of Safety Statistical Programming must effectively interface with team members… more
- Amgen (Thousand Oaks, CA)
- …alongside other innovative, driven professionals in this meaningful role. Observational Research Manager - Oncology **Live** **What you will do** Let's do this. ... facing team supporting the BLINCYTO and xaluritamig programs. An Observational Research Manager is recognized as a strong scientific contributor and is a first… more
- Sanofi Group (Cambridge, MA)
- …to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty Care MAP and ... management. + Significant experience in Medical Governance, Medical Quality, Pharmacovigilance , Regulatory Affairs, Medical Operations (at global and affiliate… more
- AbbVie (Worcester, MA)
- …Instagram, YouTube and LinkedIn. Job Description We're seeking a Quality Assurance Manager to ensure compliance and efficiency in our quality system for drug, ... quality regulations: drug, biologics, device and/or combination products. + Lead project teams in planning, preparation, review and approval of quality… more
- Endo International (Malvern, PA)
- …Degree preferred. + Eight (8) years of experience in pharmaceutical drug safety/ pharmacovigilance case processing including branded and generic products and all case ... and logical in approach to all assigned tasks + Strong leadership & project management skills. Ability to manage multiple priorities and manage resources to drive… more
- Merck (Columbus, OH)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities… more
- Boehringer Ingelheim (Ridgefield, CT)
- …members, encourage cross-functional coordination and coordinate with the (senior) regulatory project manager to achieve regulatory milestones & deliverables. The ... Oversee the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager . + Support submission rollout for Rest of World (RoW)… more