- Sumitomo Pharma (Springfield, IL)
- …+ Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a ... Experience in oncology is highly desired + **Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and… more
- Sumitomo Pharma (Springfield, IL)
- …Strategic Alliance (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will be responsible for ... with Quality on corrective action and preventative actions relevant to pharmacovigilance including but not limited to documentation of quality review findings,… more
- Astellas Pharma (Northbrook, IL)
- …packages. The VP will partner with key stakeholders in development, pharmacovigilance , clinical operations, medical affairs, and commercial strategy to drive an ... approaches in portfolio decisions. + Support clinical development, regulatory, pharmacovigilance , and medical affairs by integrating RWE into clinical plans,… more
- United Therapeutics (Springfield, IL)
- …role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, ... or related field + 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a...bachelor's degree or + 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a… more
- Astrix Technology (Chicago, IL)
- …responses to health authority inquiries. + Stay current with global pharmacovigilance regulations and guidelines to ensure compliance and best practices. ... relevant specialty is preferred. + Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry. + Strong… more
- AbbVie (North Chicago, IL)
- …to support potential product related issues *Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global Medical Affairs (GMA) and Clinical ... device/ combination product vigilance (safety signal detection, data mining techniques, pharmacovigilance / device vigilance databases, etc.) + Track record of… more
- Astellas Pharma (Northbrook, IL)
- …senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of medical ... and Early Development and Translational Sciences. + Partner with Pharmacovigilance /Medical Safety Leads to ensure optimal standards, processing, collection and… more
- AbbVie (North Chicago, IL)
- …study protocols and informed consents. When appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, ... residency with patient management experience 2. 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry 3. Effectively… more
- Lundbeck (Deerfield, IL)
- …+ Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs. + Detailed understanding and ... ability to apply concepts of legal/regulatory requirements and guidelines to the pharmacovigilance business + Ability to work well with modest supervision in a… more
- Astellas Pharma (Northbrook, IL)
- …. Collaborate within Development: o Development o Regulatory Affairs o Pharmacovigilance . Collaborate with divisions outside of Development: o Market Access ... o Commercial o Human Resources o Legal o Ethics & Compliance **Qualifications** **Required** Educational Background: + US: Doctorate Degree in Health-Related Sciences: ie: MD, PhD, PharmD, DNP, DO Years of Experience: + Minimum 5 years scientific/medical… more