- Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT)
- …from Start of Development to Loss of Exclusivity. Plan and execute non-clinical safety studies and pre-clinical safety assessments at appropriate stages ... will be the primary interface with global health authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as a **Senior** ** Principal Pharmacovigilance Scientist** where you will provide pharmacovigilance ... will contribute:** + Technically fully competent to perform all usual Principal Pharmacovigilance Scientist/Senior Pharmacovigilance Scientist workload,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …from Start of Development to Loss of Exclusivity. + Plan and execute non-clinical safety studies and pre-clinical safety assessments at appropriate stages to ... will be the primary interface with global health authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In… more
- ThermoFisher Scientific (Wilmington, NC)
- …now and in the future. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs ... concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies . + Discusses all medical concerns with principal investigators… more
- Bausch + Lomb (Harrisburg, PA)
- …Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug/Device Safety , and Clinical Supplies), ... sites with CRAs as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff.… more
- ThermoFisher Scientific (Greenville, NC)
- …one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and ... required). **Discover Impactful Work:** Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line… more
- IQVIA (Durham, NC)
- …including + protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. + Performs medical review of the protocol, ... review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department. + May provide medical support for the Analysis of Similar… more
