- Astellas Pharma (Northbrook, IL)
- …present data, strategy and risk assessment. **Preferred:** + 5 years' experience in drug safety or pharmacovigilance is preferred + Early Development ... Following entry into development, the EDSP serves as the drug safety lead on the Asset Team,...Quality Framework. + Provides effective communication and training to pharmacovigilance teams (eg, Safety Science, Epidemiology, Operations)… more
- US Tech Solutions (Madison, NJ)
- …Life Sciences, Information, or similar background (Bachelors, Masters) * 5+ years Drug Safety / Pharmacovigilance experience * Advanced Tableau, Spotfire, ... **Title:** ** Pharmacovigilance (PV) Analytics and Reporting Specialist** **Duration :...from the Source to Target * Support program and project team activities required to implement innovation initiatives. *… more
- AssistRx (Maitland, FL)
- …Life Sciences, etc.) or equivalent experience required. + 7+ years of experience in pharmacovigilance / drug safety , with 3+ years in a compliance, oversight, ... The Manager, Pharmacovigilance - Front End Operations will lead frontline...to ensure consistent alignment with global regulatory requirements for drug safety , reporting, and risk management. This… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- …PV Standard Operating Procedures, Work Instructions and Guidance. + Liaise with Global Pharmacovigilance personnel. + Support strategy and project plan for the ... Job Title Pharmacovigilance Intern Requisition JR000014766 Pharmacovigilance Intern...post-marketing adverse event filings to the US Food and Drug Administration received globally. The PV Summer Intern will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or + RN degree preferred **Experience Qualifications** + 4 or More Years drug safety experience with technical experience in Electronic Data Capture and ... with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks...experience in one or more of the following areas: Drug Safety , Epidemiology, and Clinical Development preferred… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to global process improvements. Develops and provides mentorship to enable project teams to embrace pharmacovigilance initiatives and strategic remits. ... Patient Safety within Gilead; Identifies and leverages advances in pharmacovigilance where appropriate, such as use of artificial intelligence, real-world data,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …or coach direct reports to provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... in the global CREA (CNS, Retinopathy and Emerging Areas) Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …clinical research, or other related healthcare environment, including significant experience working in drug safety /PV or a related field OR + MA/MS/MBA in life ... Under the guidance of the Executive Director of Kite Safety & Pharmacovigilance (PV), you are responsible...other related healthcare environment, including significant experience working in drug safety /PV or a related field will… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …actively involved in regulatory inspections/review of responses impacting Global Patient Safety and Pharmacovigilance programs, as appropriate. + Stay informed ... products that are benefiting millions of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available… more
- System One (Jersey City, NJ)
- …Project Management is responsible for providing support to regional and global Drug Safety Pharmacovigilance (PV) projects. Projects include global ... invoice processing. The position is located within the specialized Drug Safety Project Management Office...support Global Safety Teams (GST) as a project manager with responsibility to track pharmacovigilance … more
- BeiGene (San Mateo, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees. ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report… more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... and from post-marketing sources, providing medical expertise to assigned project teams, the identification and investigation of safety...+ Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial… more
- United Therapeutics (Columbus, OH)
- …aspects of drug development & registration of medicines, ensuring their safety + Strong analytical thinking to diagnose common situations, gather and review ... plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position… more
- Gilead Sciences, Inc. (Foster City, CA)
- …minimum of 6 years' experience in pharmacovigilance with substantial knowledge of drug safety including medical review of ICSRs. + Extensive knowledge of US ... Safety Reporting. + Industry experience of clinical safety , pharmacovigilance operations, and medical review. Oncology...Board certification is strongly preferred. Significant experience working in drug safety / PV or a related… more
- Lundbeck (Deerfield, IL)
- …EDUCATION, EXPERIENCE, and SKILLS:** + Accredited MD/DO (MBBS, MBCHb, MBBCh) + 5+ years drug safety experience in a biotech or pharmaceutical company + Ability ... accountable for medical-scientific interpretations of aggregate data **Other Organizational Project Assignment** + Participation in relevant cross functional/GPS projects...to drive drug safety evidence generation and risk mitigation… more
- Sanofi Group (Cambridge, MA)
- …data validation and review processes, support the CRD for the Clinical Case review ( safety events reported to Pharmacovigilance or safety events of special ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...trials for Tolebrutinib, from scientific assessment of a clinical project to final deliverable. The applicant must be able… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 to support drug development processes and global submissions. This position also...working knowledge of medical terminology capture and reporting of safety data, pharmacovigilance , industry best practices, and… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …Provide leadership regarding PV activities to ensure accurate maintenance and reporting of adverse drug events and other critical safety and PV data as required ... all change management, document control, training, compliance, complaint management, Pharmacovigilance Operations (adverse event reporting for pharmaceutical/medicinal products), internal… more
- Sanofi Group (Cambridge, MA)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... new indications The CRD: + Reports to the Global Project Head + Interacts with the other CRDs in...with functions to ensure full strategic and operational alignment ( pharmacovigilance , regulatory ) We are an innovative global healthcare… more
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