- United Therapeutics (Indianapolis, IN)
- …and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety ... ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting… more
- Sumitomo Pharma (Indianapolis, IN)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- Cardinal Health (Indianapolis, IN)
- …policies regarding Medical Drug Information, including any MSL presentations and Medical/ Safety Review Committees + Provides pharmacovigilance support through ... internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying customer needs or knowledge gaps to… more
- Sumitomo Pharma (Indianapolis, IN)
- …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
- Lilly (Indianapolis, IN)
- …a scientific and operationally capable workforce skilled and knowledgeable in pharmacovigilance and signal management including safety surveillance, signal ... and pharmacovigilance . + Partner closely with other Global Patient Safety , Regulatory, Development and other functions to effectively plan, forecast, and manage… more
- Lilly (Indianapolis, IN)
- …GPS are committed to collecting, monitoring, evaluating, and communicating high-quality safety information through the science of pharmacovigilance . The purpose ... looking to make a significant contribution to public health and patient safety through the practice of pharmacoepidemiology?** We are seeking an ambitious… more
- Lilly (Indianapolis, IN)
- …minimization activities globally. This role plays a critical role in ensuring the safety and efficacy of our products while also maximizing their value to patients. ... of the GPS Benefit-Risk Management group, providing strategic leadership for Safety Science related activities and representing benefit-risk management and Safety… more
- United Therapeutics (Indianapolis, IN)
- …+ 5+ years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety and Medical Science, ... background in nursing or pharmacy and you're passionate about pharmacovigilance ! You are a team player who loves quality,...are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality,… more
- Lilly (Indianapolis, IN)
- …with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s') life cycle. ... partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership. The CRP is the… more
- Lilly (IN)
- …the world. **Purpose:** The Sr. Director PV Case Management Individual Case Safety Reporting (ICSR) provides technical leadership for the design, development, and ... relationships. In addition, the Sr. Director leads global projects involving complex safety systems, ensuring strategy and risks are considered, lessons learned are… more