[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).
• 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.

Requirements

• Demonstrated ability to plan, prioritise, and coordinate multiple concurrent client activities and deliverables across a cross-functional team, within a regulated environment.
• Proven ability to represent MC professionally, manage client expectations, and build productive, long-term working relationships with client stakeholders at all levels.
• Ability to provide functional direction, motivate, and develop a project team without formal line management authority; strong influencing and negotiation skills.
• Ability to accept responsibility and account for his/her actions and those of the project team within the scope of the engagement.
• Ability to perform work accurately and thoroughly, maintaining high standards of quality in a regulated, deadline-driven environment.
• Ability to assess complex operational and regulatory situations, identify root causes, and drive resolution.
• Ability to pay close attention to the details of project deliverables, compliance documentation, and client communications.
• Ability to identify and proactively address operational, regulatory, and relationship challenges.
• Ability to actively attend to, convey, and understand the comments and questions of clients, team members, and internal stakeholders.
• Ability to communicate clearly and concisely in writing across a range of formats including client correspondence, project plans, compliance reports, and SOPs.
• Ability to communicate complex PV and project management matters effectively to diverse internal and external audiences.
• Ability to address client needs while adhering to MCI's procedures, standards, and quality requirements.
• Ability to work with initiative, manage competing priorities, and drive outcomes independently in a fast-paced, matrixed environment.
• Possesses the trait of being well organised and following systematic methods of managing project activities, documentation, and communications.
• Ability to complete assigned tasks and maintain quality standards under stressful conditions and tight regulatory timelines.
• Ability to conform to a set of values and accepted standards; maintains the highest levels of integrity in all client and regulatory interactions.
• Demonstrated ability to work effectively in a matrix environment.
• Fluent in English; proficiency in additional languages is an advantage.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance and wellness programs.
• Flexible working hours and remote work options.
• Professional development and training opportunities.
• Generous vacation and leave policies.