- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and process improvements. + Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidence + ... Argus Safety backend database. + Strong knowledge of Oracle Argus Safety System , PV Case Intake, PV Reports, Signal Detection and Analytics Reporting… more
- United Therapeutics (Columbus, OH)
- …for cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key ... role in management and oversight of end-to-end case safety management activities spanning across our global commercial product...with vendors and other team members of GPS & PV to ensure process compliance + Training and Development:… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …in this mission? We are seeking a highly motivated individual to join us as an Associate Director , Patient Safety Risk Management. Under the guidance of the ... Executive Director of Kite Safety & Pharmacovigilance ( PV ), you are responsible for contributing to the initiation, management, and execution of key… 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, ... the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be...create Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation within their program +… more
- Ascendis Pharma (Palo Alto, CA)
- …mark. We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Medical Safety Science reports to Head of Global ... Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position oversees the creation of SAE Flow ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization...for CS Physician and Data Management for study related safety reporting. Will also act as PV … more
- Actalent (Remote, OR)
- Description The PV Operations, Associate Director is accountable for the development and execution of global pharmacovigilance processes and deliverables. ... be considered. Skills pharmacovigilance, Inspection readiness, Compliance, Vendor management, drug safety , PV Operations, cross functional teams, DSPV, FDA, EMA,… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. **Global Safety Associate Director , Obesity, US - Remote** **Live** **What you will ... change the world. In this vital role the Global Safety Associate Director will work...activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Pharmacovigilance, Patient Safety , Epidemiology, and Quality (PSEQ) Business Process Office is comprised ... 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
- AbbVie (Branchburg, NJ)
- …for early development assets *Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents *Analyze and interpret ... Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose Responsible for supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical … 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
- Takeda Pharmaceuticals (Boston, MA)
- …Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the ... team on quality compliance activities. + Provide guidance and support to GCP, PV Health Authority inspections including logistics. + Present insights to the health… more
- Boehringer Ingelheim (Ridgefield, CT)
- …**_Candidate will be hired_** **_at level commensurate with experience and education._** ** Associate Director Requirements:** + US MD or DO degree or ... accredited institution and more than 2 years of applicable experience, required. **Sr. Associate Director Requirements:** + US MD or DO degree or international… more
- Boehringer Ingelheim (Ridgefield, CT)
- …**_Candidate will be hired_** **_at level commensurate with experience and education._** **Sr. Associate Director Requirements:** + US MD or DO degree or ... **Description** The (Senior) Patient Safety Physician will join our motivated and expert...environment). + In addition to global responsibilities, may represent PV at US-specific cross-functional meetings that require Risk Management… more
- Lilly (Rockford, IL)
- …visits if necessary. + Inform properly and in a timely manner to TS/MS Associate Director about project status, issues, etc. Identifying issues root case and ... control (for parenteral product) strategies and post commercialization validation process ( PV /PPQ) and oversight any documentation associated as required. + Ensure… more