- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a… more
- Integrated Resources, Inc (Cambridge, MA)
- Job Title: Senior Drug Safety Specialist Location: Cambridge, MA Duration: 8+ Months Job Description: Duties: . Reporting to the Associate Director, Drug ... Safety and Pharmacovigilance Compliance and Operations, you... activities, supporting records management and compliance across the clinical development and marketing programs. You will be a… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and guidelines + Expertise in therapeutic products and areas; medical coding; safety -data administration + Pharmacovigilance Specialist should possess ... is preferred (MS, Pharm.D.) + At least one year of relevant experience in pharmacovigilance , clinical research, or regulatory affairs in a CRO or a… more
- Merck (Austin, TX)
- **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through ... clinical trials and surveillance, we ensure the ...products to produce safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist , Associate Director,… more
- ThermoFisher Scientific (Cambridge, MA)
- … background preferred. Experience * Must have at least 2 years of relevant clinical , research and/or Drug Safety experience. * Completion of GCP, MedDRA, and ... development and delivery of life-changing therapies. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data… more
- Lilly (Indianapolis, IN)
- …purpose of the Clinical Research Scientist, GPS Medical is to perform clinical safety functions within Global Patient Safety Medical, including ... Developmental Core Safety Information, Risk Profile, Risk Management Plans, Summary of Clinical Safety and Core Data Sheet.Take part in and guide the… more
- Organon & Co. (Plymouth Meeting, PA)
- …into fully implemented and operating Organon processes to secure an industry-benchmarked clinical development and clinical safety organization, operating in ... plan, scientifically sound, feasible to execute, efficient and in line with Good Clinical and Good Pharmacovigilance Practice (GCP and GPvP). + Ensure excellent… more
- University of Southern California (San Diego, CA)
- …to development of Safety Management Plans, Medical Monitoring Plans, Clinical Monitoring Plans, Pharmacovigilance Plans, and Risk Management Plans + ... issues. + Interacts with medical monitors and site clinical monitors to provide support to medical safety...project team meetings. + Assists in overseeing the Medical Safety Specialist team within the Medical … more
- Randstad US (Cambridge, MA)
- …and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance . + To better serve the ... guidance of the CRD he/she collaborates with the Coding specialist , Biostatisticians, Data Managers, Global and Regional Study Managers,...the CRD for the Clinical Case review ( safety events reported to Pharmacovigilance or … more
- Lilly (Indianapolis, IN)
- …Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise working across Lilly's device product portfolio to lead ... related Doctoral or Graduate level degrees: PhD, PharmD, Nursing with advanced clinical specialty ( Clinical Nurse Specialist /Nurse Practitioner). + Combined… more
- Bristol Myers Squibb (Minneapolis, MN)
- …of gaps in FM resources; collaborates with the Field Medical Communication Specialist (FMCS), TA point, Medical Information and Medical Strategy on development of ... stakeholders and then mobilizing them to respond to customer needs ** Clinical Trial/Site Identification & Support** + Tracks FM region activity toward… more
- AbbVie (Mettawa, IL)
- …and their reports across different products. + Participation in design and execution of clinical trial safety , product safety and risk management plans. May ... trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI… more
- Bristol Myers Squibb (San Francisco, CA)
- …oversight of MSLs in support of BMS medicines and all phases of associated clinical trials. The RAD oversees their regional team to ensure disease and product ... of gaps in FM resources; collaborates with the Field Medical Communication Specialist (FMCS), TA point, Medical Information and Medical Strategy on development of… more
- Boehringer Ingelheim (Ridgefield, CT)
- … expertise in medical coding (MedDRA and WHO Drug Global) both for clinical study databases and the global safety database, including the conception, ... study databases as well as in the global safety databases for usage of MedDRA and WHO Drug...related trainings. + Firm knowledge of regulatory environment in Pharmacovigilance and GCP. + Experience with clinical … more
