- Merck (Rahway, NJ)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... Intellectual Curiosity, Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance , Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Requirements,… more
- Lilly (Indianapolis, IN)
- …Lead Safety Physician + Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s): + In early phase development, performs ... + Receptive, engaging, and impactful contributor + Clinical development or pharmacovigilance experience preferred + Knowledge of drug development process + Fluent… more
- Sanofi Group (Morristown, NJ)
- …Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts: ... Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts:… more
- AbbVie (North Chicago, IL)
- …of this position. Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of ... authority . 5 - 7 years of experience in Quality Assurance and/or Pharmacovigilance An equivalent combination of education and experience may be accepted as a… more
- Bristol Myers Squibb (Baltimore, MD)
- …provide key scientific updates to internal stakeholders (eg Commercial, Regulatory, Pharmacovigilance , Legal, HEOR, Value Access & Payment) + Provide scientific ... agreed upon with home office medical and GDO + Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies,… more
- Ascendis Pharma (Palo Alto, CA)
- …of the JD. Key Responsibilities + Collaborate with Clinical Development, Pharmacovigilance , Biometrics, Core Team Members, Product Management, and Leadership teams ... + Work closely with Commercial, Clinical Development, Medical Affairs, Pharmacovigilance , Biometrics, Core Team Members, Product Management, and Leadership teams… more
- IQVIA (Durham, NC)
- …review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department. + May provide medical support for the Analysis of Similar ... Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department. + May perform medical review of adverse event coding. + Performs review of the… more
- TEKsystems (Morrisville, NC)
- …and regulations for the programs/promotions + Identify and report pharmacovigilance information as required by client(s)(ie, Adverse Events)-(specific to ... + Conducts miscellaneous tasks or projects as assigned. Identify and report pharmacovigilance information as required by client(s) (ie, Adverse Events) - (specific… more
- Astellas Pharma (Cambridge, MA)
- …senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of medical ... publications. -Play a strategic lead role in collaboration with Pharmacovigilance /Medical Safety to ensure optimal standards, processing, collection, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Clinical Program Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, deviation management, Serious… more
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