- Accenture (Chicago, IL)
- …partner Provide subject matter expertise in R&D technologies such as EDC, CDMS, RIM, Safety DB, PLM, QMS, etc. Typical projects consist of a definition of an R&D ... areas: product design, product, and clinical development / operations, pharmacovigilance , regulatory, medical affairs, patient services, MD&D (medical device and… more
- Parexel (Springfield, IL)
- …this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned ... all Key Performance Indicators (KPIs) for the process + Function as pharmacovigilance representative/ safety scientist + Attend/support Bid defense meetings +… more
- AbbVie (North Chicago, IL)
- …detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Location: Open ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety … more
- Parexel (Springfield, IL)
- …**medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional ... **Medical Monitor** for gastroenterology studies, ensuring scientific integrity and patient safety + Provide expert medical oversight throughout the clinical trial… more
- Astellas Pharma (Northbrook, IL)
- …exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety / pharmacovigilance (PV) statistics, statistical programming, biomarker ... genetics experts in oncology + RWE analysts/statistical epidemiologists + Safety /PV statisticians + Advanced analytics and modeling specialists + Ensure… more
- Sumitomo Pharma (Springfield, IL)
- …clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety -related issues, ... Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health… more
- Cytel (Springfield, IL)
- …skill set, the role may also include strategic consulting on clinical, safety / pharmacovigilance , regulatory, and market access pathways to accelerate patient ... access to new health technologies. **Client Leadership & Strategic Advisory** + Serve as an externally recognized thought leader in clinical development, regulatory strategy, market access strategy, and quantitative clinical methods. + Provide strategic… more
- Sumitomo Pharma (Springfield, IL)
- …with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- AbbVie (North Chicago, IL)
- … pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports. 4. Apply current regulatory ... pipeline and considered for future opportunities. Medical Directors within the Patient Safety , Epidemiology and Quality team are responsible for the following: 1.… more
