English Language Manager

1 month ago


Windsor, Windsor and Maidenhead, United Kingdom Parkside Recruitment Full time
Job Title: English Language Manager

The successful candidate will be responsible for maintaining and creating departmental procedures, including Standard Operating Procedures (SOPs), to ensure compliance with regulatory and global requirements. They will also support EU affiliates in performing pharmacovigilance activities according to SOPs and regulatory requirements.

Key Responsibilities:
  1. Provide support for APVC activities, including addressing and coordinating PV-related issues with global or local functions.
  2. Organize and support periodic or ad hoc trainings or meetings with local and global PV teams.
  3. Support global PV teams in implementing new procedures, systems, and requirements.
  4. Support the establishment of a compliant PV system in affiliates.
  5. Monitor and support local PV system improvement in affiliates.
  6. Oversee applicable written PV procedures in affiliates.
  7. Review and provide PV-relevant inputs for GSOPs from the LSMs/LPPV/LPVCP perspective.
  8. Act as a subject matter expert for APVC-related subjects in PV-related regulatory inspections or quality assurance/corporate compliance audits.
  9. Ensure work is properly documented and filed.
  10. Support, review, and QC assigned PSMF Annexes, as applicable.
  11. 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:
  1. Education in healthcare or life sciences, preferably at bachelor level or higher.
  2. Minimum 3 years' experience in PV or PV-related areas in the pharmaceutical industry or Health Authority.
  3. Good knowledge of PV-related regulations.

The ideal candidate will have a strong understanding of pharmacovigilance regulations and procedures, as well as excellent communication and organizational skills. They will be able to work effectively in a team environment and provide support to EU affiliates in performing pharmacovigilance activities.



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