- Merck & Co. (North Wales, PA)
- …strategies that meet regulatory requirements and ensure patient safety, quality and compliance.-Oversee PV processes: Responsible for overseeing ... Human Use (ICH) guidelines.-Maintain quality standards: Responsible for maintaining high- quality standards for PV processes and systems, and for implementing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy and operations.- Supports Head Global Strategy and Operations for Global RD/ PV /MA QA relevant activities including QQR, monthly quality report, team ... of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training...agenda and meeting minutes.- Involve and attend the Global RD/ PV /MA QA strategic meeting and create the draft of… more
- Integrated Resources, Inc (Cambridge, MA)
- …MA Duration: 8+ Months Job Description: Duties: . Reporting to the Associate Director , Drug Safety and Pharmacovigilance Compliance and Operations, you ... functionally with Client teams, CRO's and vendors. . Contribute to the quality management Drug Safety system including: ensuring department standards are met,… more
- Merck (West Point, PA)
- …pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance. + Oversee PV processes: Responsible for ... Use (ICH) guidelines. + Maintain quality standards: Responsible for maintaining high- quality standards for PV processes and systems, and for implementing … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …strategy and operations. - Supports Head Global Strategy and Operations for Global RD/ PV /MA QA relevant activities including QQR, monthly quality report, team ... of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training...and meeting minutes. - Involve and attend the Global RD/ PV /MA QA strategic meeting and create the draft of… more
- Boehringer Ingelheim (Athens, GA)
- …they are in compliance with current regulations and laws. + Support global and local PV Teams as needed. + Work with Quality Teams to investigate any relevant ... **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance (...drug safety and/or quality signals and to initiate any relevant CAPAs. +… more
- Bristol Myers Squibb (Madison, NJ)
- …(EDSR). Authors safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER), Development Safety ... requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , Medical Coding, Analytics & Process is responsible for ... develop, and maintain metrics and algorithms to measure coding quality and support quality review. The incumbent...and GCP. + Experience with clinical trial databases and/or PV databases. + Experience in vendor management and oversight.… more
- Philips (Colorado Springs, CO)
- ** Director , Clinical Affairs (Plymouth, Colorado Springs, or San Diego)** The Associate Director , Clinical Affairs will aid in advancing care and improving ... decide, guide, treat and confirm across the peripheral vascular ( PV ) portfolio in our Image Guided Therapy Devices business....won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- NiSource (Valparaiso, IN)
- …integration with other project management information systems with data quality /data integrity assurance to create integrated project baselines Provides cost ... for implementation of corrective action. + Ensures estimate and budget quality management in accordance with project management industry standards. Ensures… more
- Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ)
- …Vaughan, Ontario FLSA (Exempt/Non-Exempt) - Exempt POSITION SUMMARY Reporting to the Associate Director , Regulatory Affairs, this position is responsible for ... product listing in coordination with marketing. + Assist the Associate Director of Regulatory Affairs on assigned...+ Provide regulatory guidance and support to R&D, Clinical, PV , and QA, as well as in the development… more
- Lilly (Indianapolis, IN)
- …portfolio (if required). + Inform properly and in a timely manner to TS/MS Associate Director about project status, issues, etc. Identifying issues root case and ... owning the process control strategy including the key process parameters, critical quality attributes. + Understanding product history and potential failure modes of… more
- Novo Nordisk (Plainsboro, NJ)
- …other safety information for all Novo Nordisk products. Relationships Reports to Associate Director , Patient Safety Training. Internal relationships include all ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....of safety information to relevant internal stakeholders eg external PV stakeholders eg vendor(s) + Develop and maintain functional… more
