VP of Pharmacovigilance

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

To support our growth, we are seeking a strategic, collaborative and client-focused leader to operate as Vice President of PV Services & EUQPPV. This is key role where you will be leading Clinigen’s global pharmacovigilance operations and driving the growth of our PV service portfolio. This senior leadership role requires strategic oversight, operational excellence, and exceptional client engagement skills. Managing a global team of 30 delivering end-to-end PV services, including clinical trials support, post-approval safety monitoring, and commercialisation, while ensuring the highest standards of quality and regulatory compliance including fulfilling the role of the EU/UK QPPV.

This is a client-facing role that will involve supporting business development efforts, contributing to proposals and bid defences whilst maintaining strong relationships with regulatory authorities and clients.

Strategic Leadership:

• You will lead a highly skilled global team of 30 PV specialists across all levels of seniority.
• Provide strategic guidance on PV operations to meet evolving client needs and global regulatory requirements and technical developments such as generative AI and ML.
• Act as the principal expert for pharmacovigilance during client interactions, audits, and regulatory inspections.
• Manage the pharmacovigilance team; recruit, develop and mentor staff.
• Promote and act to protect patient and public health.
• Expand PV service offerings and support the company’s growth objectives either through internal growth, external partnerships or companies’ acquisitions.
• Serve as the EU QPPV with full responsibility for the establishment and maintenance of the company’s and clients’ pharmacovigilance system.
• Provide strategic direction and leadership to the internal PV team and clients, ensuring effective collaboration and communication.
• Support strategic decision-making regarding risk-benefit assessments, product safety profiles, and lifecycle management.
• Provide tailored PV consultancy services to clients, ensuring regulatory expectations are met or exceeded.

Client Engagement & Business Development:

• Serve as the primary PV subject matter expert (SME) in client proposals, bid defences, and strategic planning discussions.
• Build and maintain trusted relationships with clients, offering tailored solutions to meet their PV needs.
• Support business development teams by identifying new opportunities to enhance PV services and expand the client base.

Oversee all aspects of PV operations, including:

• Clinical Trial Support: Safety monitoring, adverse event reporting, and safety management plans for clinical development programmes.
• Post-Approval & Commercialisation Support: End-to-end PV services, including risk management plans, signal detection, and aggregate reporting.
• Case Processing & Safety Reporting: Ensure accurate and timely processing of ICSRs and adherence to reporting timelines.
• Signal Detection & Risk Management: Lead signal detection activities, risk-benefit evaluations, and implementation of risk minimisation measures.
• Aggregate Reporting: Oversee the preparation and submission of periodic safety reports (e.g., PSURs, DSURs, PBRERs).
• Regulatory & Medical Services: Ensure high-quality medical reviews and compliance with global regulatory requirements.

 Audits & Compliance:

• Ensure the PV team is always audit-ready, maintaining compliance with client contracts, regulatory standards (e.g., MHRA, EMA, FDA, ICH GVP), and internal SOPs.
• Maintain oversight of the Pharmacovigilance System Master File (PSMF) and ensure it is accurate and up to date.
• Act as the primary contact point for the EMA and national competent authorities on PV matters, including inspections.
• Oversee/manage the preparation, hosting, and follow-up of pharmacovigilance audits and regulatory inspections.
• Foster a culture of quality and continuous improvement within the PV function.

Requirements

• Bachelor's Degree in Biological/Life Sciences, pharmacy or medicine or equivalent
• At least 15 years’ experience in the Drug Safety field in the Pharmaceutical Industry  
• Experience of working in a service provider (e.g. CRO) EU-registered QPPV with a minimum of 5 years' experience in a senior pharmacovigilance role.
• Proven leadership experience in managing cross-functional teams and vendors.
• Proven expertise in global PV regulations, clinical trial safety, and post-market safety monitoring.
• Demonstrated experience in supporting business development activities, including client proposals and bid defences.
• Familiarity with PV systems (e.g., Argus, ArisG) and data analysis tools for signal detection and reporting.
• Ability to align PV operations with business goals and regulatory landscapes.
• Proven ability to lead, inspire, and grow a diverse global team.
• Up-to-date knowledge of GVP, ICH guidelines, and regional regulatory requirements, with a commitment to quality and compliance.
• Skilled in managing complex projects, balancing multiple priorities, and delivering on time and budget.
• Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus
• Understanding of impact of emerging regulatory requirements and technical developments such as generative AI and implications for Clinigen and clients
• Excellent oral and written communication skills and commitment to mentoring / training PV team
• Experience in inspection preparation and demonstrated success in representing GVP in an inspection or audit

If you’re ready to take your career to the next level and make a lasting impact on a growing organisation, we want to hear from you!