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Affiliate PV Operations Manager

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), as well as supporting EU affiliates in the performance of pharmacovigilance activities according to SOPs and regulatory requirements.

**Key Responsibilities**

  • Provide support for APVC activities, including addressing or coordinating PV-related issues with relevant global or local functions for resolution.
  • Organize and support periodic or ad hoc trainings or meetings with local and global PV teams.
  • Support global PV teams to implement new procedures, systems, and requirements.
  • Support the establishment of a compliant PV system in affiliates.
  • Monitor and support local PV system improvement in affiliates.
  • Oversee applicable written PV procedures in affiliates.
  • Review and provide PV-relevant inputs for GSOPs from the LSMs/LPPV/LPVCP perspective.
  • Act as a subject matter expert for APVC-related subjects in PV-related regulatory inspections or quality assurance/corporate compliance audits and support with deviations and CAPAs, as required.
  • Ensure work is properly documented and filed.
  • Support, review, and QC assigned PSMF Annexes, as applicable.
  • 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**