Global PV Regulatory Intelligence & Partnerships Lead

Clinigen; Weybridge; On-site; GBP 70,000 - 95,000; 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 with global requirements and patient safety commitments.

The role serves as the regulatory intelligence SME, monitoring evolving legislation and guiding cross-functional teams to implement changes and maintain an effective global pharmacovigilance framework.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine or related discipline.
• Significant experience in pharmacovigilance with knowledge of global regulations.
• Experience negotiating and managing pharmacovigilance agreements and external partnerships.
• Strong communication and stakeholder management skills across global teams.
• Proficiency with MS Office and pharmacovigilance systems.

Responsibilities

• Lead development, negotiation, implementation and maintenance of pharmacovigilance agreements and partnerships.
• Serve as SME for global pharmacovigilance regulatory requirements and regulatory intelligence activities.
• Monitor evolving pharmacovigilance legislation and guidance and assess impacts on processes and compliance.
• Coordinate cross-functional implementation of regulatory changes and monitor ongoing compliance.
• Develop and maintain a global network of pharmacovigilance partners and consultants.
• Provide oversight of partner compliance, including audits and governance meetings.
• Support clients and internal stakeholders with expert advice on pharmacovigilance requirements, including early access and unlicensed medicines.
• Build relationships with clients, alliance partners, regulatory authorities.

Skills

Pharmacovigilance experience

Communication and negotiation

Project and stakeholder management

MS Office & pharmacovigilance systems

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine or related field

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 with global requirements and patient safety commitments.

The role serves as the regulatory intelligence SME, monitoring evolving legislation and guiding cross-functional teams to implement changes and maintain an effective global pharmacovigilance framework.