- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a regulated GCP environment or equivalent experience preferred- Experience in Clinical Safety and Pharmacovigilance preferred- Medical Affairs experience ... Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of interventional, non-interventional, investigator-initiated… more
- Merck & Co. (Rahway, NJ)
- …quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies...and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic ... that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process...and may also participate on a non-project initiative in support of these objectives. This position will report to… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. ** Pharmacovigilance Scientist, Senior Manager ** **Live** **What you will do** Let's do ... provides oversight to staff with regards to safety in clinical trials Review and provide input and support...of role and responsibility + Processes and regulations for pharmacovigilance and risk management + Drug development and lifecycle… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Senior Manager , Pharmacovigilance (PV) Business Partner Relations in Lexington, MA with ... the following requirements: Bachelor's degree in Clinical , Regulatory Affairs, Pharmacy, or related field or foreign academic equivalent plus 5 years of related… more
- Johns Hopkins University (Baltimore, MD)
- …Research Site Manager_** who will deliver to and organize work plans with collaborating 20+ clinical sites across the country in support of clinical trial ... teams on schedule with established performance expectations. + Provide support to quality assurance monitors in all facets of...+ Experience in a higher education environment. Classified Title: Clinical Research Site Manager Job Posting Title… more
- Actalent (Cambridge, MA)
- …* Assist in developing and automating a standardized and custom standards library for clinical data review and decision support within studies and across TAs for ... experience * Work collaboratively with cross-functional stakeholders, including Drug Safety, Clinical Data Management & Standards, and Digital, to implement best and… more
- Merck (Columbus, OH)
- …quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams ... **Job Description** Our Clinical and Pharmacovigilance teams manage studies...and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable… more
- Boehringer Ingelheim (Ridgefield, CT)
- …budgets to deliver best in industry direct to patient, healthcare provider (including clinical support staff) and patient advocacy market segment education. The ... to grow beyond current allocation) to provide education to Multidisciplinary Clinical Support Staff (inclusive of specialty physicians, advanced practice… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as chairperson the output of cross-functional evidence team ( Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, ... Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans or similar documents, Core Clinical Trial Protocols,… more
- AbbVie (North Chicago, IL)
- …who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, ... representative for key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... evidence, and creating hope for all facing illness. The Manager , Drug Safety Aggregate Reports will function as the...and contract updates related to drug safety vendors and support the logistical management of global safety governance escalation… more
- Sanofi Group (Bridgewater, NJ)
- **Regional PV Manager ** Internal posting title: Deputy Country Safety Head, US and Canada **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Job Type:** Full ... of the CSH. + Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. +… more
- BeiGene (San Mateo, CA)
- …evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and ... the monitoring of the safety of patients on allocated clinical trials. + Lead the development of safety contents...approval of amendments and contribute to safety summaries to support changes to the CCDS. + Contribute to development… more
- BeiGene (Emeryville, CA)
- …in collaboration with Safety Science team members and relevant cross-functional team members ** Clinical Trial Support ** + Lead the review of safety data and ... specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related...RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members + Support … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Manager , Drug Safetywill support signal detection activities and medical analyses ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic ... that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process...and may also participate on a non-project initiative in support of these objectives. This position will report to… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …is to support the Global Patient Safety (GPS) department in business support of safety systems utilized for pharmacovigilance . This includes overseeing daily ... FDA, EU and ICH (International Conference on Harmonization) regulations governing clinical and post-marketing pharmacovigilance activities + Familiarity with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. ... of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring requirements. Works closes with other functional groups such as… more
