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Pharmacovigilance and Scientific Information Director
2 months ago
We are seeking an experienced and dynamic Pharmacovigilance and Scientific Information Manager to join our Scientific Affairs team at RBW Consulting. As a key member of our team, you will be responsible for ensuring the highest standards of safety and information management.
Key Responsibilities- Develop and Implement Safety Strategies: Drive the development and implementation of pharmacovigilance and scientific information strategies, processes, and platforms, ensuring alignment with regulatory requirements and industry best practices.
- Lead Regulatory Compliance: Serve as the primary liaison with regulatory bodies, maintaining oversight of all regulatory cases, ensuring compliance, and leading the development of regulatory submissions.
- Manage and Mentor Teams: Oversee a team of professionals, providing leadership, mentorship, and guidance, while managing resources to ensure the accurate and timely processing of safety information.
- Ensure Quality and Compliance: Maintain and improve pharmacovigilance and scientific information processes, ensuring they are always audit-ready and compliant with regulatory standards.
- Collaborate with Global Teams: Work closely with our global regulatory and medical affairs teams to ensure that local activities support and enhance global initiatives.
- Expertise: A life science degree or qualification as a health professional, with 5-10 years of experience in pharmacovigilance and regulatory affairs.
- Leadership 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 bodies, healthcare professionals, and industry associations.
