Project Manager – Life Sciences; Pharmacovigilance

Position: Project Manager – Life Sciences (Pharmacovigilance)
Location: Naperville

Project Manager – Life Sciences (Pharmacovigilance)

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

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field; advanced degree (MS, MPH, Pharm
  
  D, or MBA) preferred.
• 5+ years of project management experience in the life sciences industry, with a minimum of 3 years in pharmacovigilance or drug/device safety.
• 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, Veeva Vault Safety, Salesforce-based platforms).
• Proven ability to lead cross-functional teams and manage multiple complex projects simultaneously.
• PMP, PRINCE2, or similar project management certification preferred.
• Familiarity with tools such as Microsoft Project, Smartsheet, Jira, Confluence, or similar project management platforms.
• Excellent communication, interpersonal, and stakeholder management skills.

Why Join Us

• Be part of an innovative and mission-driven organization focused on advancing patient safety and regulatory excellence.
• Collaborate with a high-performing, cross-functional team and global stakeholders.
• Opportunity to work on cutting-edge projects involving next-gen PV technologies, AI-driven safety, and unified platforms.

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