- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV /MA Quality) and in close collaboration… more
- Aequor (San Diego, CA)
- …oversight. Author responses for safety data queries and contribute to specified PV sections. Ensure pharmacovigilance regulatory compliance with oversight, ... strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary /… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and partner PV audits. Review and ensure compliance with PV Agreements and the regulatory labeling portion of contracts with partner companies. ... Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, regulatory , and business perspectives to ensure compliance with evolving… more
- Tris Pharma (Monmouth Junction, NJ)
- …and inspection readiness of Drug Safety team at all times; Ensures internal regulatory / PV processes and procedures are well documented and support compliant ... regulatory / PV activities Reviews safety data exchange and/or ...with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other ... DSPV subject matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits.Ensure that a risk-based audit plan is… more
- Insmed Incorporated (Bridgewater, NJ)
- …of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product ... drug safety partners, CROs, professional consultants, and /or contractors to ensure compliance with company policies and regulatory requirements on safety data… more
- American Honda Motor Co Inc (Torrance, CA)
- … compliance and operation. Required documentation must clear necessary regulatory , compliance clearances, as well as legal approval.Qualifications, ... services and telematics is a plus.Experience with home battery ESS, solar PV a plus.Experience with project development involving app, server, partner, hardware,… more
- Sanofi Group (Bridgewater, NJ)
- …and Maintenance of** ** PV Operating &** **Safety Management System** In compliance with PV regulatory requirements and company procedures/guidelines, + ... activities in the assigned country are performed in compliance with the Global PV policies, as...CSH + PV Zone Leads + Regional PV Head + Country Medical/ Regulatory /Quality Teams and… more
- Sanofi Group (Bridgewater, NJ)
- …and other functions in compliance with global procedures and local regulatory PV requirements + To systematically evaluate the availability of resources ... Responsibilities** This is a Leadership member of the CHC PV Operations team and reports to the CHC ...procedures and systems in line with changes in the regulatory environment and best industry practices. + He/She is… more
- Taiho Oncology (Princeton, NJ)
- …outside of Taiho (such as Business partners). + Effectively manage to ensure compliance with regulatory submissions and internal timelines. + Participate in ... Associate Director, PV Sciences Pleasanton, CA, USA * Princeton, NJ,...preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members. + Maintain… more
- CSL Behring (King Of Prussia, PA)
- …Safety Science such as signal detection, PV Operations and data analytics, PV Compliance , Affiliate management, Donor Safety oversight, to place CSL's Safety ... used to treat serious and often rare conditions. Could you be our next Director, PV Strategy and Operations Excellence? The job is located in the King of Prussia or… more
- NextEra Energy (Tucson, AZ)
- …troubleshooting, and maintenance, overall site operations, asset management and regulatory compliance , reliability engineering, and inventory management. **Job ... ** PV Solar Field Technician II - Wilmot Solar...duties and Inventory management + Heavy equipment operation + Regulatory compliance + Performs other job-related duties… more
- NextEra Energy (Lee, IL)
- …troubleshooting, and maintenance, overall site operations, asset management and regulatory compliance , reliability engineering, and inventory management. **Job ... ** PV Solar Field Technician III - Illinois** **Date:**...duties and Inventory management + Heavy equipment operation + Regulatory compliance + Performs other job-related duties… more
- Ameresco (Framingham, MA)
- …of reports, presentations, documentation, and related project material. + Ensure compliance with company, industry, trade, and regulatory safety, standards, ... will provide team support throughout the construction of multi-million-dollar Solar PV and Battery Energy Storage System projects. Responsibilities + Assist the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …establish in-built controls in relevant process steps to ensure adherence to regulatory compliance . + Monitor effectiveness of implementation of applicable ... the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV /MA Quality) and in close collaboration… more
- NextEra Energy (Johnston, RI)
- …troubleshooting, and maintenance, overall site operations, asset management and regulatory compliance , reliability engineering, and inventory management. **Job ... ** PV Solar Field Technician I** **Date:** May 1,...duties and Inventory management + Heavy equipment operation + Regulatory compliance + Performs other job-related duties… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management in Cambridge, MA with the following requirements: Master's ... degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or life sciences...Report (DSUR), Periodic Adverse Drug Experience Report (PADER/PAER) in compliance with global regulations. Up to 5% travel required.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development and maintenance, regulatory operations and filings-related activities including regulatory submissions, regulatory compliance , regulatory ... and review submission packages, labeling revisions, and promotional materials for regulatory compliance including supporting launch and market growth for… more
- Boehringer Ingelheim (Athens, GA)
- **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance ( PV ) team to ensure compliance with all regulations and laws worldwide ... Risk/Benefit balance of our veterinary products. + Supporting Global PV in the analysis and reporting of AE data...regulatory agencies in a timely manner. + Maintains compliance with corporate procedures and with global regulations and… more
