- Lilly (IN)
- …patient safety policies and procedures. + Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration ... with global patient safety. + Provide appropriate oversight and partnership with Third Party Organizations and sites to ensure successful study execution. **Scientific Data Dissemination/Exchange** + Knowledge of and compliance with local laws and regulations,… more
- AbbVie (North Chicago, IL)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly… more
- AbbVie (Florham Park, NJ)
- …for key regulatory discussions. *Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + *Bachelors degree in the sciences; advanced degree (eg, MS, PhD) preferred *At least 8 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent. *Ability to run a complex… more
- Sanofi Group (Morristown, NJ)
- …clinical & safety substantiation + Understand the basic framework for Pharmacovigilance processes, Toxicological assessments, and Regulatory for the cosmetic & OTC ... industry. **_Why us?_** At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where… more
- TEKsystems (Morrisville, NC)
- …in internal department meetings as needed. * Identifies and reports pharmacovigilance information as required by client(s) (ie, Adverse Events). * Conducts ... miscellaneous tasks or projects as assigned Skills Pharmaceutical, healthcare customer service, billing and reimbursement software, case management, Quality assurance, Compliance, Quality control, supervisory skills, medical billing, medical insurance, call… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …document repositories per Medical Affairs SOPs and processes. + Coordinate with Pharmacovigilance , Quality and Regulatory Affairs to respond to external audits and ... requests from external regulatory bodies. + Manage the pre-fair market value (FMV) evaluation of proposed study budgets and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …project management, clinical monitoring, data management process, regulatory affairs, pharmacovigilance , etc.) to enable meaningful dialogue within Takeda and with ... partners. + Proven experience in Alliance/Partnership excellence: deep understanding/experience of building, maintaining, and closing partnerships including tools/methods. + Expertise in the ability to perform root cause analysis, develop corrective actions,… more
- Bristol Myers Squibb (Dallas, TX)
- …agreed upon with home office medical and GDO + Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, ... and alert appropriate BMS personnel to any identified Adverse Events + If applicable, support CRO sponsored studies as agreed with home office medical and GDO and as defined by the study scope document **Required Qualifications & Experience:** + MD, DO,… more
- Takeda Pharmaceuticals (Boston, MA)
- …compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. + Oversees ... and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. + Responsible for evaluation of external interactions in the context of overall development… more
- Sanofi Group (Atlanta, GA)
- …relevant products in the Vaccine portfolio and pipeline. + Good knowledge of pharmacovigilance and local regulatory process and its impact on the Vaccine portfolio + ... Strong business acumen, understanding importance of and being able to build strategic plans and implement Medical initiatives. + Seen as role model, upholding integrity and ethics values and adhering to high standards **Why Choose Us?** + Bring the miracles of… more
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