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- ...of the PV system in compliance with local regulations and internal company timelines/standards. For individuals acting as National QPPV / back up National QPPV, as per country attestation form: Maintains oversight of AbbVie\'s PV system master file (PSMF) with the authority...SuggestedLocal 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$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- ...The Section Director, Inspection Excellence serves as a key leadership role within the Inspection Excellence team, reporting to the QPPV & PV Excellence team in Global Patient Safety. This position is responsible for leading a team of direct reports and collaborating with...SuggestedWorldwide
- ...Strong knowledge of global PV regulations and pharmacovigilance workflows (case processing, signal detection, aggregate reporting, QPPV interactions). Demonstrated experience managing software/technology projects, especially PV or clinical systems (e.g., Argus, ArisG,...SuggestedFull time
$180k - $195k
...inspections or internal quality assurance/corporate compliance audits Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Safety Science teams for assigned activities Is responsible for any assigned US applicable Risk Management...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$180k - $195k
...inspections or internal quality assurance/corporate compliance audits Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Safety Science teams for assigned activities Is responsible for any assigned US applicable Risk Management...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$186k - $233k
...audit findings of Summits 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...SuggestedFull timeSummit Therapeutics Sub, Inc.
Menlo Park, CA22 hours ago$186k - $233k
...documentation. Provide ongoing support during inspections and develop responses to regulatory findings. Partner closely with PSPV, QPPV Office, and cross-functional teams to support successful and compliant execution of Summit PSPV activities. Actively lead the...SuggestedFull timeSummit Therapeutics, Inc.
Menlo Park, CA22 hours ago$284k - $355k
...aggregate reporting process and other processes as needed. Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable. Contribute to the development and maintenance of a PV quality system in line with global...SuggestedFull timeContract workLocal areaREVOLUTION Medicines
Redwood City, CA2 days agoAssociate Director, Global Patient Safety Quality and Compliance - Pharmacovigilance (San Francisco)
$186k - $233k
...safety requirements related to safety science processes. Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable. Support GPS management in ensuring inspection readiness for global inspections by ensuring...SuggestedFull timeContract workLocal areaRevolution Medicines
San Francisco, CA22 hours ago
