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Clinical - Pharmacovigilance (PV) Scientist
MADISON, NJ, UNITED STATES
Position is OnsiteFunctional Area DescriptionThe Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety...
Pharmacovigilance Project Manager
SAN FRANCISCO, CA, UNITED STATES
Job DescriptionTHE POSITION:This position is the front line contact with the pharmacovigilance (PV) client. In addition to client interaction, the individual serves as a reference to the team for the client's products and is responsible for project planning, execution and budget planning...
Data Architect with Pharmacovigilance experience- Onsite
RARITAN, NJ, UNITED STATES
Own the end-to-end architecture of the modern Safety/Pharmacovigilance Data Platforms which ingests data from the several systems across clinical, non-clinical systems and transforms it into insights for internal and external users using a scalable big data pipeline on GCP.Pharmacovigilance...
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Finance Lead Pharmacovigilance, Patient Safety, Epidemiology, and R&D QA
NORTH CHICAGO, IL, UNITED STATES
Job DescriptionThe R&D Pharmacovigilance, Patient Safety, Epidemiology, and R&D Quality (PSEQ) Finance Lead supports the leadership in the planning and execution of both current and long-term strategies around resource and budget management. The primary function of the PSEQ Finance Lead...
Associate Director, IT Product Ownership - Job ID: 1407
PALO ALTO, CA, UNITED STATES
...our global Medical and Pharmacovigilance (Drug Safety) teams with technology. You will partner with the medical and pharmacovigilance teams and lead the product discovery efforts. You will prioritize the work to be delivered by the product teams and help do the work where you can contribute...
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Associate Director Global PV Operations, Oncology - Job ID: 1405
PALO ALTO, CA, UNITED STATES
...etc.) Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and other Service Providers (SPs) vendors. These activities include, but is not limited to: Ensuring SP/vendor...
Senior Associate, Aggregate Report Compliancet.
RARITAN, NJ, UNITED STATES
...AffairsInternational Pharmacovigilance LeadershipOther partners across businessQuality Management ReviewsMedical Safety Council Operational Compliance CommitteesOther compliance review venues and for other functional partnersKey Requirements and Technology Experience: Key Skills...
Director, Drug Safety Operations
SOUTH SAN FRANCISCO, CA, UNITED STATES
...risk management and pharmacovigilance for all clinical trials.ResponsibilitiesManage SAE/SUSAR reporting activities for all investigational drugsManage preparation and processing of internal and external SAE reportsReview incoming adverse events to determine action requiredOversee...
Sr Medical Director, Product Safety Lead
NORTH CHICAGO, IL, UNITED STATES
...write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports. Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents...
Project Manager
NORTH CHICAGO, IL, UNITED STATES
Job Responsibilities: \" Responsible for reviewing projects on a quarterly basis to ensure they are compliant from a pharmacovigilance, OEC and Finance perspective. - Identify projects that have been closed - Review to ensure the following - Pharmacovigilance is marked...
Project Manager
NORTH CHICAGO, IL, UNITED STATES
...are compliant from a pharmacovigilance, OEC and Finance perspective. - Identify projects that have been closed - Review to ensure the following - Pharmacovigilance is marked appropriately - OPI record is accurate & closed out - Ensure all final documents are attached \" Final...
Medical Director I
CHICAGO, IL, UNITED STATES
...support for global pharmacovigilance of assigned products as needed, including the review and analysis of safety data from clinical studies, the post-marketing setting, and the scientific literature; assistance with signal assessments; assistance with the preparation and review of aggregate...
Pharma Program Manager
PHILADELPHIA, PA, UNITED STATES
...non-AMS) program and pharmacovigilance experience are big pluses. Roles & ResponsibilitiesDay-to-day program lead and primary interface to business and IT executive leaders and stakeholdersLeads project team in delivering new design & build Digital transformation solution including...
Sr Medical Director, Product Safety Lead
NORTH CHICAGO, IL, UNITED STATES
...regulations related to pharmacovigilance supporting all patient safety activities.Responsibilities:Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillanceResponsible for safety surveillance for pharmaceutical...
Director I/II, Epidemiology - Oncology
NORTH CHICAGO, IL, UNITED STATES
...regulatory science and pharmacovigilance, as applicable to RWD/RWE. Responsibilities: Represent Global Epidemiology on cross-functional, matrix sub-teams of overall asset development teams. As the Global Epidemiology Asset Strategy Lead, develop and execute the function s RWE strategy...
Sr Associate IS Prog Analyst
THOUSAND OAKS, CA, UNITED STATES
...support to Pharmacovigilance operations teams for defined applications and tools: Monitor PV Ops applications performance and troubleshoot/escalate issues as applicableAddress teams applications requestsBuild libraries, workflows, forms, etc. as necessaryAssist with special...
Director, Epidemiology - Immunology
NORTH CHICAGO, IL, UNITED STATES
...regulatory science and pharmacovigilance, as applicable to RWD/RWE.Responsibilities:Represent Global Epidemiology on cross-functional, matrix sub-teams of overall asset development teams.As the Global Epidemiology Asset Strategy Lead, develop and execute the function s RWE strategy plan for...
Sr Associate IS Prog Analyst ( Sharepoint)- 100% Remote: Contract.
THOUSAND OAKS, CA, UNITED STATES
...support to Pharmacovigilance operations teams for defined applications and tools:a. Monitor PV Ops applications performance and troubleshoot/escalate issues as applicable.b. Address teams applications requests.c. Build libraries, workflows, forms, etc. as necessary.2. Assist...
Senior Specialist Quality Assurance - Level III (Senior) 100% remote
JERSEY CITY, NJ, UNITED STATES
...framework governing pharmacovigilance and safety surveillance at our client.Qualifications:Advanced knowledge of end-to-end PV procedural requirementsAbility to review/direct PV procedural documents to ensure compliance with international standards and regulations while also promoting a...
Senior Drug Safety Case Manager
SOUTH SAN FRANCISCO, CA, UNITED STATES
...guidelines and good pharmacovigilance practicesParticipate in training internal and external audiences on drug safety-related topics, as assigned.Guide departmental policies and procedures by maintaining a high level of understanding of federal and international regulationsDraw upon the...
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