The Pharmacovigilance Regulatory Intelligence & Partner Alliance Manager is responsible for overseeing the lifecycle of pharmacovigilance agreements and partnerships, ensuring compliance with global pharmacovigilance requirements and supporting the safe and effective management of medicinal products across international markets.
The role acts as a subject matter expert in pharmacovigilance regulatory intelligence, monitoring evolving regulatory requirements and ensuring that company processes, procedures and partner agreements remain compliant with applicable legislation and client expectations. Working collaboratively with internal stakeholders, clients and external partners, the role plays a key part in maintaining an effective global pharmacovigilance framework and supporting Clinigen's commitment to patient safety.
Key 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.
Requirements
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.
What We're Looking For
- A proactive and solutions-focused approach.
- Strong attention to detail and commitment to quality and compliance.
- Ability to manage multiple priorities in a fast-paced and evolving environment.
- A collaborative team player with the confidence to influence and engage stakeholders at all levels.
- Passion for patient safety and maintaining high standards of pharmacovigilance compliance.