Project Manager – Life Sciences (Pharmacovigilance)

Project Manager – Life Sciences (Pharmacovigilance)

Location : West Coast, USA

Job Type : Full-time

About the Role

We are seeking a highly motivated Project Manager with deep experience in pharmacovigilance and life sciences to lead cross-functional safety and regulatory projects. This individual will oversee the planning, execution, and delivery of projects related to drug and device safety operations, regulatory compliance, and pharmacovigilance systems implementation. The ideal candidate brings proven expertise in global PV regulations, cross-functional coordination, and stakeholder communication, ensuring projects are delivered on time, within scope, and in compliance with regulatory standards.

Key Responsibilities

• Lead end-to-end project management for pharmacovigilance and drug safety initiatives, including PV system implementations, process improvements, and compliance programs.
• Define project scope, goals, timelines, resource plans, and deliverables in collaboration with stakeholders and leadership.
• Develop and maintain comprehensive project documentation including project plans, status reports, risk logs, and communication plans.
• Coordinate cross-functional teams including Safety, Regulatory Affairs, IT, Clinical Operations, and QA to ensure seamless project execution.
• Ensure compliance with global pharmacovigilance requirements (e.g., ICH E2E, GVP Modules, FDA, EMA).
• Drive readiness and execution of safety data migration, audits / inspections, and regulatory submissions.
• Facilitate regular project status meetings and stakeholder updates; proactively identify and mitigate risks and roadblocks.
• Manage vendors and external partners involved in safety operations and system implementations.
• Monitor project budgets, timelines, and performance metrics; escalate issues as needed to senior leadership.

Qualifications

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At Cloudbyz, our mission is to empower our clients to achieve their business goals by delivering innovative, scalable, and intuitive cloud-based solutions that enable them to streamline their operations, maximize efficiency, and drive growth. We strive to be a trusted partner, dedicated to providing exceptional service, exceptional products, and unparalleled support, while fostering a culture of innovation, collaboration, and excellence in everything we do.

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