- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …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
- United Therapeutics (Philadelphia, PA)
- …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 (Harrisburg, PA)
- …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
- CVS Health (Blue Bell, PA)
- …engagement and drive growth across our Real-World Evidence (RWE) generation, Safety & Surveillance ( pharmacovigilance ) and Clinical Trial Recruitment ... + Serves as a subject matter advocate for CVS Healthspire's, RWE, Safety , and Clinical Trial Recruitment offerings. + Leverages a strong understanding of… more
- CVS Health (Blue Bell, PA)
- …and client engagement efforts across our Real-World Evidence (RWE) generation, Safety & Surveillance ( pharmacovigilance ) and Clinical Trial Recruitment ... capabilities. This leader will be responsible for developing a high-performing team, executing the go-to-market strategy, cultivating high-impact partnerships across life sciences and government industries, and driving growth of LSS product offerings. This… more
- Sanofi Group (Swiftwater, PA)
- …(CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, safety surveillance) + ... May represents Sanofi Vaccines BIOS group externally in interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees + May act as the lead statistician at clinical trial level and provides… more
- Sumitomo Pharma (Harrisburg, PA)
- …and effectiveness checks. + Contributes to standard operating procedures relevant to pharmacovigilance . + Assist with other Safety department activities as ... (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will...Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team… more
- United Therapeutics (Harrisburg, PA)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- J&J Family of Companies (Horsham, PA)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Product Safety **Job Sub** **Function:** Product Safety Risk Management **Job ... are searching for the best talent for a Manager, Safety Analysis Scientist to be located in Horsham, PA;...of relevant experience is required. + Medical writing or Pharmacovigilance (PV) experience is required. + Working knowledge of… more
- Merck (West Point, PA)
- …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