- Careerbuilder-US (Atlanta, GA)
- …the safety team for assigned products and activities and will have the medical safety expertise to perform obligatory safety functions with oversight ... Job Title: Medical Director/Global Safety Physician Job Location:...global pharmacovigilance of assigned products as needed, including the review and analysis of safety data from… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …of individual adverse event case report processing, triage and medical review is preferred Experience with safety databases (Argus preferred) and ... the Pharmacovigilance & Risk Management Team, the Senior Director, Medical Safety Physician will be responsible for...for investigational and marketed products. Perform critical and strategic review of safety data in support of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an exempt level position responsible for reviewing...in a controlled GMP environment. Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview ... The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...commercial operations in a controlled cGMP cleanroom environment. Create, review and approve relevant QC documents, logbooks, SOP's and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the company and clinical site investigators and KOLs Interface together with VP Medical /Scientific Development with Safety Review Committees and Data ... Safety Monitoring Committees Participate in safety review meetings and providing medical monitoring of ongoing clinical trials Physical Requirements… more
- Taiho Oncology (New York, NY)
- …Fulfills Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Uses medical ... Sr. Medical Science Liaison New Jersey, USA New York,...Investigator-Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review and follow-up of submitted IITs in assigned territory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates ... relevant medical topics, and supports PV Operations' medical review function. This position supports a...medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing… more
- Taiho Oncology (TX)
- …Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical ... Medical Science Liaison Texas, USA Virtual Req #330...Investigator-Initiated Trials (IITs) and HCP initiated projects. Facilitate the review and follow-up of submitted IITs. Assist with Taiho… more
- Eisai, Inc (Nutley, NJ)
- …grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...including (but not limited to) CRC, scientific communications, publication planning/ review , advisory boards, health outcomes plans, MSL activities, speaker… more
- Eisai, Inc (Nutley, NJ)
- …grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...including (but not limited to) CRC, scientific communications, publication planning/ review , advisory boards, health outcomes plans, MSL activities, speaker… more
- Option Care Health (Columbus, OH)
- …provider, we have an undeniable responsibility to protect the health and safety of our patients, customers and team members.Option Care Health requires that ... will be contingent upon proof of vaccination, or approved medical or religious accommodation. Proof of vaccination will be...Employee will further help to manage this system and review such data to create marketing reports for Management… more
- GXO (Columbus, OH)
- …compensation and a generous benefits package, including full health insurance ( medical , dental and vision), 401(k), life insurance, disability and more.What you'll ... CDC, OSHA and state and local requirements regarding COVID safety . All employees and visitors are expected to comply...perform duties outside of their normal responsibilities from time to time, as needed. Review GXO's candidate privacy statement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, ... medical history, and medications when needed- Addresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, ... allocation, budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage asset protocolsCore… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product safety lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …advice to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure ... limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion Diagnostics/ Device Laboratories… more
- Insmed Incorporated (Bridgewater, NJ)
- …safety aspects in the Medical Monitoring Meeting Collaboration in Safety Management TeamProvide medical /scientific review of statistical analysis. ... the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for… more
- Uline (Columbus, OH)
- …and monitor safety goals.Take part in new product / process review , including process hazard analysis.Participate on Uline's Safety Committee. Review ... As EHS Coordinator at our new Ohio branch, promote safety programs that reduce risks to our people and...packages weighing up to 50 - 70 lbs. BenefitsComplete medical , dental, vision and life insurance coverage, Flexible Spending… more
- Eisai, Inc (Nutley, NJ)
- …and their staff regarding AE's from clinical trials. 30%Assist in projects requiring review and assessment of medical information obtained or related to adverse ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...event reports received for assigned product, including the timely review and distribution to co-marketing partners and Eisai affiliate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE)- Direct Project Support:… more
