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Pharmacovigilance and Scientific Information Director
2 months ago
Job Summary
RBW Consulting is seeking an experienced and dynamic Pharmacovigilance (PV) and Scientific Information (SI) Manager to lead the way in ensuring the highest standards of safety and information management.
About the Role
As the PV and SI Manager, you will be responsible for:
- Developing and Implementing PV and SI Strategies: Drive the development and implementation of PV and SI strategies, processes, and platforms, ensuring that they align with regulatory requirements and industry best practices.
- Leading the UK Pharmacovigilance System: Serve as the primary liaison with regulatory authorities, maintaining oversight of all UK PV cases, ensuring compliance, and leading the UK pharmacovigilance system master file (PSMF).
- Managing and Mentoring a Team: Oversee a team of professionals, providing leadership, mentorship, and guidance, while managing resources to ensure the accurate and timely processing of safety information.
- Maintaining Compliance and Quality: Maintain and improve PV and SI processes, ensuring they are always audit-ready and compliant with regulatory standards.
- Collaborating with Global Teams: Work closely with our Global Pharmacovigilance and Medical Affairs teams to ensure that local activities support and enhance global initiatives.
Requirements
To be successful in this role, you will need:
- Expertise in Pharmacovigilance: A life science degree or qualification as a Health Professional, with 5-10 years of experience in pharmacovigilance.
- Leadership and Management Skills: Previous line management experience and the ability to inspire and develop your team.
- Regulatory Knowledge: A thorough understanding of regulatory requirements, industry best practices, and GxP standards.
- Communication Skills: The ability to represent the company with external stakeholders, including regulatory authorities, healthcare professionals, and industry bodies.