Global PV Regulatory Intelligence & Partnerships Lead

Clinigen; Burton upon Trent; On-site; GBP 90,000 - 125,000; Full time

Job summary

Clinigen is seeking a Pharmacovigilance Regulatory Intelligence & Partner Alliance Manager to oversee pharmacovigilance agreements and partnerships across international markets, ensuring compliance and patient safety.

You will act as a subject matter expert on global regulatory requirements, monitor evolving legislation, and support cross-functional teams in implementing regulatory changes and maintaining an effective global pharmacovigilance framework.

Qualifications

• Essential Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related scientific discipline.
• Significant experience within pharmacovigilance, including knowledge of global pharmacovigilance regulations and requirements.
• Experience negotiating and managing pharmacovigilance agreements and external partnerships.
• Strong understanding of pharmacovigilance legislation and regulatory compliance requirements.
• Experience conducting regulatory impact assessments and implementing regulatory changes.
• Excellent project management, organisational and stakeholder management skills.
• Strong communication, negotiation and influencing abilities.
• Ability to work effectively across global, cross-functional teams.
• Proficiency with Microsoft Office applications and relevant pharmacovigilance systems.
• Desirable Experience within early access, compassionate use or unlicensed medicines programmes.
• Experience working within a commercial pharmaceutical environment.
• Experience supporting alliance management, partner governance or international vendor management activities.
• Knowledge of pharmacovigilance regulatory intelligence processes and tools.
• Experience working in a global or multicultural environment.

Responsibilities

• Lead the development, negotiation, implementation and maintenance of pharmacovigilance agreements and partnerships.
• Serve as the subject matter expert for global pharmacovigilance regulatory requirements and regulatory intelligence activities.
• Monitor and assess evolving pharmacovigilance legislation and guidance, identifying impacts to business processes and compliance obligations.
• Coordinate cross-functional implementation of regulatory changes and monitor ongoing compliance.
• Develop and maintain a global network of pharmacovigilance partners and consultants to support local pharmacovigilance activities.
• Provide oversight of partner compliance, including participation in audits, governance meetings and corrective action management.
• Support clients and internal stakeholders with expert advice on pharmacovigilance requirements, including early access and unlicensed medicine programmes.
• Build and maintain effective relationships with clients, alliance partners, industry associations and regulatory authorities.

Skills

Regulatory intelligence

Project management

Stakeholder management

Communication & negotiation

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Tools

Pharmacovigilance systems

Microsoft Office

Job description

Clinigen is seeking a Pharmacovigilance Regulatory Intelligence & Partner Alliance Manager to oversee pharmacovigilance agreements and partnerships across international markets, ensuring compliance and patient safety.

You will act as a subject matter expert on global regulatory requirements, monitor evolving legislation, and support cross-functional teams in implementing regulatory changes and maintaining an effective global pharmacovigilance framework.