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Manager, Affiliate PV Coordination Specialist

2 months ago

Windsor, Windsor and Maidenhead, United Kingdom Parkside Recruitment Full time
Job Summary

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 maintenance and creation of departmental procedures, including Standard Operating Procedures (SOPs), to support the performance of pharmacovigilance activities according to regulatory and global requirements.

Key Responsibilities
  • Provide support for APVC activities, ensuring seamless coordination and execution.
  • Address or coordinate PV-related issues with relevant global or local functions for a resolution, demonstrating exceptional problem-solving skills.
  • Organize and support periodic or ad hoc trainings or meetings with local and global PV teams, fostering a culture of collaboration and knowledge sharing.
  • Support global PV teams to implement new procedures, systems, and requirements, ensuring compliance and efficiency.
  • Support the establishment of a compliant PV system in the affiliates, ensuring adherence to regulatory standards.
  • Monitor and support local PV system improvement in the affiliates, driving continuous quality enhancement.
  • Oversee applicable written PV procedures in the affiliates, ensuring accuracy and completeness.
  • Review and provide PV-relevant inputs for GSOPs from the LSMs/LPPV/LPVCP perspective, demonstrating expertise and attention to detail.
  • Act as a subject matter expert for APVC-related subjects, providing guidance and support during regulatory inspections or quality assurance/corporate compliance audits.
  • Ensure work is properly documented and filed, maintaining a high level of organization and record-keeping.
  • Support, review, and QC assigned PSMF Annexes, as applicable, ensuring accuracy and compliance.
  • 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/Experience Required
  • Education in healthcare or life sciences (e.g., biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at bachelor level (or comparable local degree) or higher.
  • Minimum 3 years' experience in PV or PV-related areas in the pharmaceutical industry or Health Authority.
  • Speak and write English to a good standard with familiarity of English medical terms.

Good knowledge of PV-related regulations is essential for success in this role.