Affiliate PV Manager

3 weeks ago

Windsor, Windsor and Maidenhead, United Kingdom Parkside Office Professional Full time
Job Description

Parkside Office Professional is seeking a highly skilled and experienced PV Coordinator Manager to join our Global team.

Key Responsibilities
  • Support for APVC Activities
    • Provide support for APVC activities, ensuring seamless execution and compliance with regulatory requirements.
  • Issue Resolution
    • Address or coordinate PV-related issues with relevant global or local functions for a timely resolution.
  • Training and Development
    • Organize and support periodic or ad hoc trainings or meetings with local and global PV teams to enhance knowledge and skills.
  • Procedure Implementation
    • Support global PV teams to implement new procedures, systems, and requirements, ensuring a smooth transition.
  • Compliant PV System
    • Support the establishment of a compliant PV system in the affiliates, ensuring adherence to regulatory requirements.
  • System Improvement
    • Monitor and support local PV system improvement in the affiliates, identifying areas for enhancement.
  • Procedure Oversight
    • Oversee applicable written PV procedures in the affiliates, ensuring accuracy and compliance.
  • GSOP Review
    • Review and provide PV-relevant inputs for GSOPs from the LSMs/LPPV/LPVCP perspective, ensuring alignment with regulatory requirements.
  • Subject Matter Expert
    • Act as a subject matter expert for APVC-related subjects, providing guidance and support during PV-related regulatory inspections or quality assurance/corporate compliance audits.
  • Documentation and Filing
    • Ensure work is properly documented and filed, maintaining a clear audit trail.
  • PSMF Annex Support
    • Support, review, and QC assigned PSMF Annexes, as applicable, ensuring accuracy and compliance.
  • Liaison and Communication
    • Act as a liaison internally and with external pharmacovigilance service providers and business partners on drug safety and PV issues, as assigned by PV management.
Qualifications and Experience
  • Education
    • Education in healthcare or life sciences (e.g., biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at a bachelor's level or higher.
  • Experience
    • Minimum 3 years' experience in PV or PV-related areas in the pharmaceutical industry or Health Authority.
  • Language Skills
    • Speak and write English to a good standard with familiarity of English medical terms.

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