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PV Coordination Team Lead
2 months ago
About the Role
Parkside Recruitment is seeking a highly skilled Manager, Affiliate PV Coordination to join our team. As a key member of our organization, you will be responsible for ensuring the smooth operation of pharmacovigilance activities across our affiliate network.
Key Responsibilities
- Provide strategic support for pharmacovigilance activities, ensuring compliance with regulatory requirements and global standards.
- Coordinate and resolve PV-related issues with global and local functions, ensuring timely and effective resolution.
- Organize and facilitate training sessions and meetings with local and global PV teams to ensure knowledge sharing and best practices.
- Support the implementation of new procedures, systems, and requirements, ensuring seamless integration with existing processes.
- Monitor and improve local PV systems, ensuring compliance and efficiency.
- Oversee the development and maintenance of written PV procedures, ensuring accuracy and relevance.
- Provide PV-relevant inputs for global SOPs, ensuring alignment with local and global requirements.
- Act as a subject matter expert for PV-related subjects, supporting regulatory inspections and quality assurance audits.
- Ensure proper documentation and filing of work-related activities.
- Support the review and quality control of assigned PSMF Annexes.
- Act as a liaison with internal and external stakeholders, including pharmacovigilance service providers and business partners.
Requirements
- Education in healthcare or life sciences, preferably at a bachelor's level or higher.
- Minimum 3 years' experience in PV or a related field in the pharmaceutical industry or a health authority.
- Excellent written and verbal communication skills in English, with a good understanding of medical terminology.
Desirable Skills
- Good knowledge of PV-related regulations and guidelines.