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IT Project Manager – Pharmacovigilance

None • Cambridge, MA, US • published 2026-10-06 07:33:52.866517

Description

Description: We are seeking an experienced mid\-level (5\-7 years) IT Project Manager with strong expertise in Life Sciences, Good Practice (GxP) compliance, and Pharmacovigilance (PV) to lead components of a large Patient Safety/PV system replacement effort. The successful candidate will manage end\-to\-end delivery of IT initiatives involving pharmacovigilance systems, safety databases, regulatory reporting platforms, integrations, data migration, process automation, and system enhancements. This role will work closely with business, clinical, drug safety, regulatory affairs, quality, compliance, vendors, and technology teams. Requirements: **Key Responsibilities:** * Lead end\-to\-end IT projects from initiation and planning through implementation, validation, deployment, and post\-production support. * Manage projects related to: * Pharmacovigilance and drug safety systems * Safety case processing and adverse event reporting * Regulatory submissions and reporting * Signal detection and safety surveillance * Aggregate reporting, including DSURs, PBRERs, and PSURs * Product quality complaints and medical information integrations * Safety data warehouses, analytics, and dashboards...

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