- 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
- Sanofi Group (Swiftwater, PA)
- …safety evaluation reports) **About You** **Experience:** + Working knowledge of drug safety and risk management including industry experience, and ... safety expert who is responsible for performing core pharmacovigilance activities on a product, in partnership with the...Signal & Risk Management: Expertise in the collection of drug safety information from a variety of… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Description** **How you will contribute:** + Senior advisor to the Head, Patient Safety & Pharmacovigilance (PSPV) to develop, drive and implement the overall ... inspection readiness + Oversees the strategy and operational excellence of the Takeda Safety Board Office (TSBO) and Global PV Educational functions + Works with the… 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
- 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
- CSL Behring (King Of Prussia, PA)
- …of all necessary external service providers + Initiate the set-up of the safety database for the Clinical Trial to include all relevant clinical information ensuring ... with important team members eg Head of PV Systems, Project Lead Data Management and Clinical Scientists + Collaborate...Collaborate with all partners to ensure requirements for Rave Safety Gateway (RSG) tasks include review of eCRFs, mapping… 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 ... Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. The incumbent will have a strong background...to drive drug safety evidence generation and risk mitigation… 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
- Catalyst Clinical Research LLC (Raleigh, NC)
- …Project Manager and clients to ensure optimal performance and utilization of the safety project team. You will manage all aspects of multiple projects, ... are met. This may include serving as back-up for project coverage when needed. You will maintain medical understanding...a CRO or pharmaceutical company and 3 years of pharmacovigilance experience. Preferred is experience with lifecycle safety… 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
- Actalent (Piscataway, NJ)
- …medical review of serious adverse events and non-serious adverse event in support of drug safety activities for clients. Medical review of assigned cases to ... the project quality in the function of medical science, pharmacovigilance , clinical operation, and data management etc. Medical Science and Clinical Operation… 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
- Lilly (Indianapolis, IN)
- …and as a team member, using pharmacoepidemiology skills to resolve a variety of drug safety issues. **Additional Information** + This position is not permanent. ... GPS are committed to collecting, monitoring, evaluating, and communicating high-quality safety information through the science of pharmacovigilance . **Basic… 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 ... marketed drugs or devices (eg registries), from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD, ).… more
- Sanofi Group (Bridgewater, NJ)
- …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 ... Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (eg planning and review of narratives)… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …+ Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance , SVP Late Clinical Development and the ... closely with other functional areas such as commercial, regulatory, pharmacovigilance , CMC, early clinical and pre-clinical development in this...+ Will be a core member of the Global Project Team + Will have and maintain the expertise… more
- AbbVie (Irvine, CA)
- …Operations Manager, Medical Managers/Advisers; Medical Information team / specialists; affiliate pharmacovigilance / drug safety personnel + Marketing ... their leadership. + Regulatory Affairs; Legal; OEC. + US Medical Information; Pharmacovigilance . + Library Information Resources. + Regionally and HQ based GAMA… more
- Sanofi Group (Cambridge, MA)
- …+ Clinical Research Directors, Clinical Scientists, Medical review team and Coding + Pharmacovigilance (GSO, CME) as regard to safety management and case ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...from health authorities for submission dossier) for their selected project . + The _individual_ will provide appropriate scientific input… more
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