Pharmacovigilance Professional

1 month ago

London, Greater London, United Kingdom findapprenticeships.co - Jobboard Full time

Job Title: Pharmacovigilance Professional

Job Summary: We are seeking an experienced Pharmacovigilance Professional to join our team as a Patient Safety Specialist. The successful candidate will operate in this capacity for UK and Ireland, supporting management of Patient Safety operational processes and ensuring compliance with relevant pharmacovigilance (PV) regulatory requirements.

Key Responsibilities:

  • Managing the collection, processing, documentation, reporting and follow-up of all adverse event reports for all company products from Clinical Trials, Non-interventional Studies et al and any other source of information.
  • Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
  • Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Departments.
  • Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
  • Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
  • Management and maintenance of all relevant local Patient Safety databases.
  • Ensure that relevant local literature articles are screened as appropriate.

Requirements:

  • Life sciences, Pharmacy or Medical Sciences degree required (post-graduate qualification preferred).
  • Prior Pharmacovigilance experience in pharmaceutical industry - at least 1 years' experience.
  • Knowledge of pharmacological and medical terminology.
  • Quality and results oriented.
  • Competent computer skills.
  • Proactive, independent approach where needed but also comfortable with working in matrix teams at local level.

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