- Lilly (Indianapolis, IN)
- …+ Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. + Serve as an IT systems business quality ... assurance (BQA) representative for IT systems, as assigned. + Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. + Review and approve as appropriate, documents associated with the development and… more
- ThermoFisher Scientific (Waltham, MA)
- …safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on - now ... patterns, comparing effectiveness between treatments, and investigating differences in safety outcomes. \#CorEvitas Discover Impactful Work: The Biostatistician will… more
- Bayer (Cambridge, MA)
- …further seamless clinical development. The IPML is responsible for study medical/ safety aspects and risk-benefit assessments supported by Pharmacovigilance and ... while continuously implementing the patient's perspective and always ensuring patient's safety and benefit; + In preparation for assets entering the portfolio,… more
- Sanofi Group (Washington, DC)
- …expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance , regulatory affairs) as well as interact with and support ... mitigation plans etc) . + Work closely with the pharmacovigilance department to define and ensure the process of... department to define and ensure the process of safety surveillance during clinical development and design the … more
- Takeda Pharmaceuticals (Boston, MA)
- …Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the ... CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key… more
- Taiho Oncology (FL)
- …defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. + Use medical affairs plans to develop and align the tactical ... plan for Sr. Manager, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg medical territory plan Training/Education Resource: + Develop, maintain and demonstrate scientific… more
- Amgen (Washington, DC)
- …cause analysis to ensure that actions are commensurate with risks to patient safety , rights, welfare and trial integrity + Support preparation, analyze and identify ... Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities + Oversight and application of Quality Management… more
- Pfizer (New York, NY)
- …in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management + Knowledge of global safety regulations and guidelines, or ... **Why Patients Need You** At Pfizer, our Safety colleagues play a key role in connecting...innovative and efficient risk management strategies to enhance patient safety . + Collaborates in the development of innovative methods… more
- Merck (Rahway, NJ)
- …play a key leadership role in ensuring regulatory compliance, patient safety , and continuous improvement of device complaint quality systems. **Key ... with cross-functional teams (eg Manufacturing, Technical Operations, Device Development, Safety and Regulatory) ensuring timely completion and CAPA implementation +… more
- AbbVie (Mettawa, IL)
- …communications, training, and clinical value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). ... Participates in the design and execution of clinical trial safety , product safety and risk management plans....TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have… more