[Hiring] Pharmacovigilance Project Manager @Med Communications International

Role Description

The Pharmacovigilance Project Manager / Project Lead is a senior client-facing professional responsible for the end-to-end operational management of one or more assigned pharmacovigilance client accounts at Med Communications. The role serves as the primary interface between the client and the MC PV team, ensuring the timely, high-quality, and fully compliant delivery of all contracted pharmacovigilance services across case management, periodic reporting, signal detection, risk management, and related regulatory activities.

Operating at a senior level within the PV department, the PV Project Manager / Project Lead combines strong scientific and regulatory knowledge with exceptional project management, communication, and stakeholder management capabilities. The role does not carry direct line management responsibility but exercises functional oversight of PV Specialists and Sr. PV Specialists assigned to the project, coordinating their workload, guiding their day-to-day activities, and supporting their professional development within the context of the client engagement. The role reports directly to the Global Head of Pharmacovigilance and Drug Safety.

Qualifications

• Excellent working knowledge of relevant PV terminology, ICH guidelines (E2A–E2F, E2C(R2)), GCP, GVP Modules, and applicable regulatory requirements across EU, US, and UK jurisdictions.
• Advanced degree in life sciences (PharmD or MD preferred), or a relevant equivalent combination of education and pharmacovigilance experience.
• Minimum of five years of pharmacovigilance experience, including at least two years in a project management, project lead, or client-facing account management role at a PV vendor, CRO, or pharmaceutical company.
• Demonstrated ability to manage complex, multi-product client accounts across multiple PV domains (case management, periodic reporting, signal detection, risk management).
• Experience with drugs, biologics, vaccines, and/or devices is preferred.

Requirements

• Proficiency with safety databases (Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube Safety), Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), and project management or tracking tools required.
• Familiarity with literature search platforms (Embase, OvidPV, PubMed) and document management systems is an advantage.
• Working knowledge of global legal, regulatory, and compliance requirements applicable to pharmacovigilance across multiple jurisdictions (EU, US, UK, ICH).
• Experience supporting or managing regulatory agency interactions and audit/inspection preparation is preferred.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Flexible work arrangements.
• Professional development opportunities.