Project Manager – Life Sciences (Pharmacovigilance)
Location: Naperville, Illinois, USA
Employment Type: Full-Time
About the Role
We are seeking an experienced Project Manager with expertise in pharmacovigilance (PV) and life sciences to lead strategic and operational safety projects. This role will oversee the planning, execution, and delivery of initiatives related to drug and device safety operations, regulatory compliance, and PV system implementation. The ideal candidate has strong experience with global PV regulations, cross-functional coordination, and stakeholder management, ensuring projects are delivered on time, within scope, and in regulatory compliance.
Key Responsibilities
Lead end-to-end project management for pharmacovigilance initiatives, including 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 for seamless project execution.
Ensure compliance with global PV regulations (ICH E2E, GVP Modules, FDA, EMA).
Drive readiness and execution of safety data migration, audits, inspections, and regulatory submissions.
Facilitate regular project status meetings, provide stakeholder updates, and proactively identify and mitigate risks.
Manage vendors and external partners involved in PV operations and system implementations.
Monitor project budgets, timelines, and performance metrics, escalating issues as required to senior leadership.
Experience and Skills Required
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field; advanced degrees (MS, MPH, PharmD, or MBA) preferred.
5+ years of project management experience in life sciences, including at least 3 years in pharmacovigilance or drug/device safety.
Strong knowledge of global PV regulations and workflows, including case processing, signal detection, aggregate reporting, and QPPV interactions.
Experience managing software or technology projects, particularly PV or clinical systems (e.g., Argus, ArisG, Veeva Vault Safety, Salesforce-based platforms).
Demonstrated ability to lead cross-functional teams and manage multiple complex projects simultaneously.
Project management certification preferred (PMP, PRINCE2, or equivalent).
Familiarity with tools such as Microsoft Project, Smartsheet, Jira, Confluence, or similar PM platforms.
Excellent communication, interpersonal, and stakeholder management skills.
Why Join Us
Drive innovation in patient safety and pharmacovigilance operations.
Collaborate with a global, high-performing cross-functional team.
Work on cutting-edge projects including next-generation PV technologies, AI-driven safety solutions, and unified platforms.
Flexible, collaborative, and mission-driven work environment.
How to Apply
Apply today to join a global life sciences organization and lead critical pharmacovigilance projects that enhance patient safety and regulatory excellence.
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