Global PV Regulatory Intelligence & Alliance Lead

Clinigen Group; Burton upon Trent; On-site; GBP 70,000 - 110,000; Full time

Job summary

The Pharmacovigilance Regulatory Intelligence & Partner Alliance Manager at Clinigen Group oversees the lifecycle of pharmacovigilance agreements and partnerships to ensure compliance with global PV requirements and the safe management of medicinal products across international markets.

You will act as a subject matter expert in regulatory intelligence, monitor evolving regulations, coordinate cross-functional implementation of changes and maintain a network of PV partners to support local

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine or related field.
• Significant experience in pharmacovigilance, with knowledge of global PV regulations.
• Experience negotiating and managing PV agreements and external partnerships.
• Strong understanding of PV legislation and regulatory compliance requirements.
• Experience conducting regulatory impact assessments and implementing regulatory changes.
• Excellent project, organisational and stakeholder management skills.
• Strong communication, negotiation and influencing abilities.
• Ability to work across global, cross-functional teams.
• Proficiency with PV systems and MS Office.

Responsibilities

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

Skills

PV regulatory knowledge

Regulatory intelligence

Contract & partner management

Stakeholder management

Project management

Communication & negotiation

Cross-functional collaboration

Regulatory impact assessments

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Tools

PV systems

Microsoft Office

Job description

The Pharmacovigilance Regulatory Intelligence & Partner Alliance Manager at Clinigen Group oversees the lifecycle of pharmacovigilance agreements and partnerships to ensure compliance with global PV requirements and the safe management of medicinal products across international markets.

You will act as a subject matter expert in regulatory intelligence, monitor evolving regulations, coordinate cross-functional implementation of changes and maintain a network of PV partners to support local