- Merck & Co. (Rahway, NJ)
- …Policies and Procedures.Job descriptionResponsible for planning and co-ordination of pharmacovigilance (PV) audit activities within our company and externally with ... a minimum of five (5) years' experience in Quality Assurance/Auditing/ Pharmacovigilance .Excellent interpersonal skills, ie, ability to build constructive relationships,… more
- Genmab (Plainsboro, NJ)
- …internal and external stakeholders; (d) drug safety and/or pharmacovigilance experience; (e) performing ongoing surveillance (including signal detection/evaluation) ... of safety data; and (f) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections. All experience may be gained concurrently.#LI-DNIAbout YouYou are passionate about our purpose and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... and Skills:--Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business role or related industry experience preferred,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ... implementationHas a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Pharmacovigilance , Patient Safety, Epidemiology, and Quality (PSEQ) Business Process Office ... (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
- Merck (Rahway, NJ)
- …Procedures. **Job description** + Responsible for planning and co-ordination of pharmacovigilance (PV) audit activities within our company and externally with CRO's, ... with a minimum of five (5) years' experience in Quality Assurance/Auditing/ Pharmacovigilance . + Excellent interpersonal skills, ie, ability to build constructive… more
- AbbVie (North Chicago, IL)
- …to our talent pipeline and considered for future opportunities. The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the ... scientific strategy for pharmacoepidemiology and real-world evidence to support product development and safety across therapeutic areas. They will design and interpret studies, contribute to regulatory submissions, and provide expertise in regulatory… more
- Takeda Pharmaceuticals (Columbus, OH)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, MA, ... part of the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be responsible for overall leadership to support… more
- ThermoFisher Scientific (Wilmington, 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
- Takeda Pharmaceuticals (Columbus, OH)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Signal Management Process Excellence in Cambridge, MA, where ... Signal Management and Innovation (SMI) team, you will report to the Senior Director , Head, Signal Management and Innovation (SMI). You will review and support… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director of R&D Quality Systems, Strategy, and Excellence (Strategy & Innovation) is responsible for leading initiatives ... strategies that improve quality outcomes and enhance decision-making processes. The Associate Director will drive cultural change and system modernization,… 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. ... implementation + Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields… 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 ... and accountability on all processes related to procurement, vendors, compliance, pharmacovigilance and budget management activities in execution of each CI and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title** : Associate Director , CPMQ Strategy and Innovation **Location** : Cambridge, MA **About ... stakeholders. + Serves as strategic thought partner to the Head of Clinical, Pharmacovigilance , and Medical Quality (CPMQ) and the CPMQ Leadership Team, driving new… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... for patients suffering from immunological diseases. Position Summary: We seek an Associate Director , Quality Assurance to join an experienced, fast-paced and… 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 ... Skills:** + Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business role or related industry experience preferred, at… more
- Takeda Pharmaceuticals (Boston, MA)
- …CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation… more
