- AssistRx (Maitland, FL)
- The Manager , Pharmacovigilance - Front End Operations will lead frontline operational support for pharmacovigilance (PV) activities, directly interfacing ... assess quality performance of internal and external resources, regularly reporting to senior management. + Support internal and external PV audits, including audits… more
- US Tech Solutions (Madison, NJ)
- …the overall WWPS needs. The PV Analytics and Reporting Specialist reports to the Senior Manager , PV Analytics Center of Excellence, within Global Biostatistics & ... **Title:** ** Pharmacovigilance (PV) Analytics and Reporting Specialist** **Duration : 12 Months contract** **Role:** **Must be onsite 50% at Lawrenceville, NJ… more
- BeiGene (San Mateo, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase ... trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate + Support and manage GCP Quality… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence (Process & Procedure) is responsible for implementing and ... is responsible for ensuring that BeiGene's research, development, and pharmacovigilance activities comply with all relevant regulatory requirements, internal… more
- Pfizer (South San Francisco, CA)
- …unbiased, objective, in-depth insights to inform business strategies and decisions. The Senior Manager is a strategic thought partner to cross-functional teams, ... industry regulations and legal requirements. Collaborate with legal, compliance, and pharmacovigilance teams as needed. + Maintain detailed records of research… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing ... relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments +… more
- System One (Jersey City, NJ)
- …knowledge of Drug Safety, MS Project and MS Excel. POSITION OVERVIEW/SUMMARY The Senior Drug Safety Specialist / Safety Manager , Project Management is ... + Manage and support Global Safety Teams (GST) as a project manager with responsibility to track pharmacovigilance activities/safety signal management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …safety signal detection and management, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP). + Knowledge of MedDRA applications / uses. + Demonstrates ... ability to analyze and resolve complex problems collaboratively with cross-functional colleagues, including ability to assess data sets and understand the safety / clinical implications. + Strong interpersonal skills and understanding of team dynamics. +… more
- AbbVie (North Chicago, IL)
- …data sources (biomarker/translational, big data, digital sources, real world data, pharmacovigilance data, clinical trial data) + Responsible for coaching, mentoring ... and performance management of direct reports. Responsible for talent development in alignment with R&D business needs + Leads cross-functional initiatives with matrixed teams; Connects with cross-functional leadership and enables analytics capabilities to… more
- University of Miami (Coral Gables, FL)
- …sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Clinical Research Project Manager supports the Office of the Vice ... studies across all stages of clinical development. The Clinical Research Project Manager reports to the Director, Clinical Research Management Support Office. CORE… more
- AbbVie (North Chicago, IL)
- …AbbVie is seeking an experienced statistician to join our growing Safety Statistics team. The Senior Manager in the Safety Statistics Group will be a member of ... are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team physicians, epidemiologists,… more
- AbbVie (North Chicago, IL)
- …data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical judgment in the assessment and reporting of serious adverse events ... strategies at a disease area and platform level. + Acts as a senior -level liaison for opinion leader interactions related to the disease area(s); partners with… more
- Sanofi Group (Morristown, NJ)
- …(non-promotional) strategy for the franchise portfolio in the US. The US Medical Manager is accountable for the medical plan within their defined franchise and scope ... Identify, establish, build, grow, and maintain strategic relationships with senior experts, key opinion leaders (KOLs), professional societies, immunization advisory… more
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