- AbbVie (North Chicago, IL)
- …The Pharmacovigilance , Patient Safety, Epidemiology, and Quality (PSEQ) Business Process Office is comprised of Business Process Owners (BPOs) who ... are accountable for the definition, health, and performance of Pharmacovigilance 's (PV's) key end-to-end processes. The BPO partners closely with process … more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Signal Management Process Excellence in Cambridge, MA, ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...Innovation (SMI) team, you will report to the Senior Director , Head, Signal Management and Innovation (SMI). You will… more
- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance (comparable to 2 years) Medical Director level requires: + Clinical ... REMS, RMP and CSR). **General Support:** Ensures tasks delegated to pharmacovigilance are properly executed. Adheres to applicable regulations and ICH guidelines… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ... alternate solutions and provide technical recommendations for Changes and process improvements. + Provide oversight, Manage Implementation and documentation of… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Director , Systems Management is responsible for the strategic oversight and day-to-day management of systems that support the delivery of regulated ... maintaining the electronic Document Management System (EDMS), acting as the Business Process Owner (BPO) for the EDMS workstream and workflows for Global… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as an Associate Director , Market Research and Competitive Intelligence, where you will be ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... Proposition: Join our dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your expertise will play a… more
- Merck (West Point, PA)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... management level. + Participates in the recruitment, interview, candidate selection process in addition to performance improvement plan/termination as necessary. +… more
- Takeda Pharmaceuticals (Boston, MA)
- By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application ... is assigned to the appropriate CPMQ team. + Lead and embed the process for collating, trending and interpretation of quality data for actionable insights including… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director , Clinical Science in our Gastrointestinal & Inflammation Therapeutic ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...to our inspiring, bold mission **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director Neurodegenerative Disorders in our Neuroscience Therapeutic Area Unit in ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Quantitative Clinical Pharmacology Lead in Cambridge, MA, where ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
- ThermoFisher Scientific (Greenville, NC)
- …communities depend on - now and in the future. **Discover Impactful Work:** The ( Associate ) Medical Director will provide medical support and medical advice for ... clinical trials and safety evaluation within the Pharmacovigilance department. **A day in the Life:** + Provide...English + Shown understanding and experience with NDA submission process . + Shown understanding of regulatory guidelines for adverse… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Pharmacometrics Lead in Cambridge, MA, where you will lead ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
- ThermoFisher Scientific (Wilmington, NC)
- …the medical content is accurate and complete. + Contributes to departmental process improvement initiatives. Clinical Trial Support: + Monitors all safety variables ... (comparable to 1-2 years) in the industry. + Direct experience in safety/ Pharmacovigilance (comparable to 2 years) **_Qualified candidates should have a background… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners. + Department Coordination:… more
- Boehringer Ingelheim (Ridgefield, CT)
- …area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. As an employee of ... meeting preparation and presentation skills. + Demonstrated understanding of the regulatory process and technical competence in core areas of drug development. +… more
- Lilly (Indianapolis, IN)
- …de-risked opportunities to evolve how Lilly and LRL operates. The **Senior Director /Executive Director ** is responsible for managing all Regulatory activities ... focus on US, UK, EU, and Canada. The Senior Director /Executive Director works with a multidisciplinary team...and understand the high-level issues affecting the drug development process and help drive effective solutions. Provide assessment of… more
- AbbVie (North Chicago, IL)
- …and IRBs regarding safety issues and queries. + May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same ... key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director , GVP QML + Engage with, ... will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and… more