Pharmacovigilance Project Manager

Pharmacovigilance Project Manager (Remote)

Position Summary

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.

Essential Functions

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statement(s):

Client and Account Management:

• Serve as the primary point of contact for all communications between the client and the MC PV team ensuring professional accurate and timely responses to all client enquiries and requests.
• Build and maintain a strong trust-based relationship with client stakeholders including the clients pharmacovigilance regulatory medical and quality teams as applicable
• Coordinate schedule and lead regular client meetings teleconferences and governance reviews; prepare agendas minutes and action items and ensure timely follow-up on all open items.
• Immediately escalate to the Global Head of PV and PVQM any breach in normal execution of contracted activities service-level deviations or issues that could impact the clients regulatory compliance position.
• Identify opportunities for additional services or expanded scope within existing client engagements and communicate these to the Global Head of PV.
• Coordinate the onboarding of new clients or new product additions including the organisation of training curricula implementation plans and system access for the assigned PV team in collaboration with the PVQM.

Operational Project Management:

• Oversee and coordinate the day-to-day PV activities of the assigned project team including case processing literature review periodic and aggregate reporting signal detection and risk management ensuring all activities are executed in compliance with applicable SOPs client-specific procedures and regulatory requirements (EMA GVP ICH FDA UK MHRA and others as applicable).
• Plan monitor and adjust resource allocation across the assigned project team to ensure adequate coverage equitable workload distribution and consistent delivery of contracted service levels.
• Maintain and regularly update project documentation tracking tools and network files to ensure completeness accuracy and accessibility for all relevant team members.
• Monitor project-level metrics and Key Performance Indicators (KPIs) identify trends or risks and proactively implement corrective measures in collaboration with the Global Head of PV.
• Coordinate directly with the PVQM and relevant internal stakeholders regarding any updated client operational procedures regulatory changes or system modifications requiring team training or process updates.
• Communicate and ensure integration of PV activities with key stakeholders for the client including the PV Physician the Qualified Person Responsible for Pharmacovigilance (QPPV) and other relevant parties.
• Collaborate with other MC departments including Medical Information Quality IT and Finance as required to deliver seamless service to the client.

Functional Team Oversight and Development:

• Exercise functional oversight of PV Specialists and Sr. PV Specialists assigned to the project providing day-to-day guidance on task prioritisation follow-up handling and adherence to client procedures without holding formal line management accountability.
• Coordinate the development and delivery of training curricula and onboarding plans for newly assigned team members ensuring all required training is documented and completed prior to task initiation in collaboration with the PVQM.
• Mentor and coach team members on PV operations client expectations and professional best practices fostering a culture of accuracy accountability and continuous improvement.
• Provide input to the Global Head of PV on team performance development needs staffing requirements and resource planning for the assigned client portfolio.

Scientific and Regulatory Contribution:

• Maintain a thorough working knowledge of relevant PV terminology ICH guidelines (E2AE2F E2C(R2)) EMA GVP Modules FDA requirements and UK MHRA guidance applying this knowledge to ensure the regulatory integrity of all project deliverables.
• Liaise with the PV Physicians and PVMW Manager or other relevant functions as applicable for scientific information exchange pertaining to case assessments signal evaluation outcomes and benefit-risk implications relevant to the clients products.
• Support the role of the QPPV in relation to regulatory reporting obligations and safety communications as required by the client engagement.
• Regularly attend process or product training sessions to maintain awareness of and knowledge of relevant regulatory and scientific updates.

Quality and Compliance:

• Maintain inspection and audit readiness for all assigned project activities at all times; actively support Quality Assurance in internal and external audits including preparation hosting and CAPA follow-up.
• Collaborate with the PV Quality Manager (PVQM) and other quality roles to ensure applicable SOPs are executed as required across the assigned project team.
• Monitor compliance against project and departmental goals; identify and report deviations from procedures and collaborate in the development implementation and timely closure of Corrective and Preventive Actions (CAPAs).
• Provide regular compliance status reports to the Global Head of PV and PVQM and where required to the client.
• Create review and provide feedback on Quality Management System documents in collaboration with the Global Head of PV and the PVQM.
• Identify opportunities for process improvement and efficiency across PV operations and contribute to the development implementation and maintenance of optimised procedures.
• Participate in or lead process improvement initiatives related to automation system upgrades or integration of safety systems as applicable.
• Comply with all applicable guidelines policies legal regulatory and compliance requirements.
• Perform other pharmacovigilance activities as requested.

POSITION QUALIFICATIONS

Competency Statements

• Excellent working knowledge of relevant PV terminology ICH guidelines (E2AE2F E2C(R2)) GCP GVP Modules and applicable regulatory requirements across EU US and UK jurisdictions.
• Project Management demonstrated ability to plan prioritise and coordinate multiple concurrent client activities and deliverables across a cross-functional team within a regulated environment.
• Client Management proven ability to represent MC professionally manage client expectations and build productive long-term working relationships with client stakeholders at all levels.
• Leadership and Influence ability to provide functional direction motivate and develop a project team without formal line management authority; strong influencing and negotiation skills.
• Accountability ability to accept responsibility and account for his/her actions and those of the project team within the scope of the engagement.
• Accuracy ability to perform work accurately and thoroughly maintaining high standards of quality in a regulated deadline-driven environment.
• Analytical Skills ability to assess complex operational and regulatory situations identify root causes and drive resolution.
• Detail Oriented ability to pay close attention to the details of project deliverables compliance documentation and client communications.
• Problem Solving ability to identify and proactively address operational regulatory and relationship challenges.
• Active Listening ability to actively attend to convey and understand the comments and questions of clients team members and internal stakeholders.
• Written Communication ability to communicate clearly and concisely in writing across a range of formats including client correspondence project plans compliance reports and SOPs.
• Oral Communication ability to communicate complex PV and project management matters effectively to diverse internal and external audiences.
• Customer Oriented ability to address client needs while adhering to MCIs procedures standards and quality requirements.
• Self-Motivated ability to work with initiative manage competing priorities and drive outcomes independently in a fast-paced matrixed environment.
• Organised possesses the trait of being well organised and following systematic methods of managing project activities documentation and communications.
• Working Under Pressure ability to complete assigned tasks and maintain quality standards under stressful conditions and tight regulatory timelines.
• Ethical 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.

SKILLS AND ABILITIES

Education: Advanced degree in life sciences (PharmD or MD preferred) or a relevant equivalent combination of education and pharmacovigilance experience.

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) is required. Experience with drugs biologics vaccines and/or devices is preferred.

Computer Skills: Proficiency with safety databases (Oracle Argus Safety ArisG LifeSphere Veeva Safety AB Cube SafetyEasy) 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.

Other Requirements: 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.

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employees ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions responsibilities skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment and the company reserves the right to change this job description and/or assign tasks for the employee to perform as the company may deem appropriate.

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