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$191.25k - $247.5k
...requires strong collaboration with cross-functional stakeholders, including R&D Quality Business Partners (QBPs), Patient Safety, and QPPV. The Director will work with stakeholders to proactively identify, evaluate, and mitigate pharmacovigilance compliance risks. In...SuggestedFull timeContract workFor contractorsLocal area- ...documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile. Supports the EU QPPV or other regional/local QP for safety issues on assigned products. Risk Management Planning & Execution: Creates strategy...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
- ...customers worldwide. This role oversees the global pharmacovigilance organization, supports the Qualified Person for Pharmacovigilance (QPPV), and partners closely with Regulatory Affairs, R&D, Commercial, Quality, and external stakeholders to safeguard Elanco's global...SuggestedFull timeLocal areaWorldwide
$65 per hour
...regulatory activities Provide safety contents for filings Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for...SuggestedHourly payContract workTemporary workWork experience placementLocal areaRemote work- ...Representative (ASR) and Medical Director technical PV learning strategy and curriculum, in partnership with Regional PV Leads, Office of the QPPV and Area PV Product Leads. Works with subject matter advisors to create content. Drives consistent implementation of the learning...SuggestedFull timeTemporary workWork at officeLocal area
$205k - $245k
...Local Pharmacovigilance and also having a functional link with the European Economic Area Qualified Person for Pharmacovigilance (EEA QPPV - dotted line reporting). The LPV Director (deputy local person responsible for pharmacovigilance) is responsible for maintaining an...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours- ...regulatory activities o Provide safety contents for filings Inspection Readiness • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness • Be representative and point of contact...Suggested
$239.25k - $398.75k
...correctly and consistently. Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV). Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team,...SuggestedLocal areaGlaxoSmithKline
Cambridge, MA4 days ago$265k - $331k
...safety requirements related to safety science processes. Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable. Responsible for ensuring inspection readiness for global inspections by ensuring all...SuggestedFull timeContract workLocal area$186k - $233k
...findings of Summit’s PV system. Post-Market / PSMF Development and Maintenance: Partner closely with members of PSPV, QPPV Office, and cross-functional teams to support the successful and compliant execution of Summit PSPV activities. Participate in...SuggestedSummit Therapeutics Sub, Inc.
Menlo Park, CA4 days ago
