- AssistRx (Maitland, FL)
- The Manager , Pharmacovigilance - Front End Operations will lead frontline operational support for pharmacovigilance (PV) activities, directly interfacing ... etc.) or equivalent experience required. + 7+ years of experience in pharmacovigilance /drug safety, with 3+ years in a compliance, oversight, or quality-driven role.… more
- Ascendis Pharma (Palo Alto, CA)
- …join Ascendis Pharma as our new Technical Business Analyst for the Pharmacovigilance IT team. Ascendis Pharma is a fast-growing biopharmaceutical company with ... you will play a crucial role in digitalizing our pharmacovigilance team as we embark on an ambitions journey...job and expand in your role, you and your manager will continuously have Impact conversations about how to… more
- US Tech Solutions (Madison, NJ)
- **Title:** ** Pharmacovigilance (PV) Analytics and Reporting Specialist** **Duration : 12 Months contract** **Role:** **Must be onsite 50% at Lawrenceville, NJ ... 08648** **Position is Onsite (Lawrenceville/New Brunswick)** Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence - JD The … more
- AbbVie (North Chicago, IL)
- …implement, maintain and monitor an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization that at a minimum meets global ... The role primarily supports all tasks associated with the implementation of the Pharmacovigilance (PV) Investigation / CAPA and Planned Deviation process within the … more
- Merck (West Point, PA)
- …Company's R&D division (our Research & Development Division) is looking for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient ... will be responsible for managing the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Job Summary:** The Manager , Medical Coding is accountable for delivery of medical coding services for ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance , CROs, and partners to ensure high quality coding deliverables are on time… more
- BeiGene (San Mateo, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase appropriate ... of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations + Ensure all logistics are arranged for any Health… more
- Amgen (Thousand Oaks, CA)
- …other innovative, driven professionals in this meaningful role. **Quality Compliance Manager , Safety & Medical Quality** **Live** **What you will do** Let's ... partners. + Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or research area. + Maintain knowledge of current regulatory and… 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 maintaining a ... is responsible for ensuring that BeiGene's research, development, and pharmacovigilance activities comply with all relevant regulatory requirements, internal… more
- United Therapeutics (Columbus, OH)
- …role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, ... Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding PM...a related field + 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a… more
- BeiGene (San Mateo, CA)
- …responsibilities not specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related duties that ... integrated Benefit/Risk assessments. + Promote and Advance the Field of Pharmacovigilance . + Responsible for effective execution, communication and influence with… more
- Daiichi Sankyo Inc. (New York, NY)
- …relevant to the marketplace, competition and the marketing team to the District Manager . + Notifies the Medical Affairs Pharmacovigilance immediately of any ... around rare diseases and immune disorders. **Summary:** The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory … more
- Johns Hopkins University (Baltimore, MD)
- …and multiple site-specific pharmaceutical sponsored trials The Sr. Research Program Manager will work in collaboration with division leadership and collaborating ... protection, federal and regulatory issues, research ethics, pharma law, pharmacovigilance , regulatory compliance, use of centralized IRBs and master agreements,… 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
- Pfizer (South San Francisco, CA)
- …objective, in-depth insights to inform business strategies and decisions. The Senior Manager is a strategic thought partner to cross-functional teams, including the ... industry regulations and legal requirements. Collaborate with legal, compliance, and pharmacovigilance teams as needed. + Maintain detailed records of research… more
- AbbVie (North Chicago, IL)
- …are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team physicians, epidemiologists, ... 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 one or more… 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
- Regeneron Pharmaceuticals (Armonk, NY)
- The Manager , Global Development Quality Standards & Continuous Improvement (GDQSCI) will support the GDQSCI team with activities related to the maintenance of the ... and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). Does this sound like you? Apply now to take… 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
- Astellas Pharma (Northbrook, IL)
- …of PV System and Oversight Responsibilities** + Provide input for the Pharmacovigilance System Master File (PSMF) regarding the local affiliate. + Ensure the ... local affiliate is PV Audit and Inspection-ready: -Act as the Astellas 'Subject Matter Expert (SME)'-Support project management related to regulatory authority, business partner or internal inspections.-Acts as the main point of contact in absence of DSO, and… more
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