Pharmacovigilance Officer

04 November 2020

Job Title: PV Officer, Grade II
Reports to: Operations Group Lead, Pharmacovigilance
Location: Harlow, Dublin and/or remote

Role Overview

We are looking for a competent and capable PV Officer Grade II with at least two years’ experience in processing ICSRs and completing QC on ISCRs. Reporting to the Operational Group Lead, you will be responsible for completing day to day pharmacovigilance activities. This is an exciting opportunity to take on a fresh challenge and develop your career with a dynamic and growing company.

Our clients range from virtual start-up companies to the largest multi-national corporations. Our expertise includes products of recombinant DNA and hybridoma technology, nucleotide based products (RNA and DNA), synthetic peptides, chemical entities (innovative and generic), vaccines (therapeutic and prophylactic), blood products and advanced therapy medicinal products (gene therapy products).

Main Responsibilities

The key responsibilities of a PV Officer Grade II include, but are not limited to:

  • Using and maintaining knowledge of the company safety database (training will be provided)
  • Performing triage (assessment) of ICSRs
  • Logging and entering cases accurately into the safety database
  • Ensuring ICSR documentation is correctly stored within the company documentation system
  • Performing accurate and timely quality control of ICSRs
  • Highlighting areas of concern and/or discrepancies to the Operational Group Lead when related to ICSRs
  • Performing literature searches and review for AEs
  • Performing Eudravigilance and XEVMPD/SPOR company and user updates and registration
  • Acquiring and maintaining up to date knowledge of global safety regulations for medicines
  • Managing and keeping up to date a personal training record
  • Performing new tasks as necessary to support the Department

The Person

The key skills and qualities of a PV Officer Grade II:

  • Has science degree; with at least 2 years’ experience in processing ICSRs and completing QC on ICSRs;
  • Able to process and QC ICSRs
  • Good understanding of Pharmacovigilance
  • Ability to report ICSRs to Eudravigilance
  • An understanding of aggregate reporting and signal detection

If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please contact us now to find out more.