Benefit-Risk Scientist: Pharmacovigilance

02 November 2020

Job Title: Benefit/ Risk Scientist, Pharmacovigilance Benefit/Risk Team
Reports to: Benefit/Risk Team Lead, Pharmacovigilance
Location: Dublin or Harlow

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Role Overview

The Benefit/ Risk Scientist (B/R Scientist) will support the PV Group Leaders and Benefit/ Risk PV Manager in ensuring that day to day operational activities are completed. The B/R Scientist may act as a PV Group Lead.

The B/R Scientist will be expected to be professional and diligent and shall liaise with Senior members in the team on any issues. The B/R Scientist is also expected to lead by example and ensure quality standards are upheld within the company.

The activities listed may not always be undertaken by the B/R Scientist, however these activities are within the remit of the role.


The applicant will require a science degree and 3+ years’ experience in Pharmacovigilance.


  • A thorough foundation in pharmacovigilance, ideally having experience in various aspects of pharmacovigilance
  • Significant experience in authoring and reviewing aggregate reports, including PSURs, PADERs, DSURs, ACOs in line with applicable templates and guidance
  • Experience in authoring and updating RMPs in line with applicable template and guidelines
  • Experience managing Company Core Data Sheets (CCDSs), including the creation and update of CCDSs, along with creating supporting documentation (e.g. Clinical Overview (CO), Clinical Expert Statement (CES), etc.)
  • Knowledge of regulatory safety variation processes
  • Broad knowledge of signal detection methodologies and modalities, and experience in authoring signal assessment reports
  • Demonstrable ability to analyse and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines
  • Keen organisational skills, with the ability to manage a dynamic workload effectively
  • Sound communication skills


  • Knowledge of pharmacovigilance processes, including ICSR processing, QC, literature searching, XEVMPD, PSMF creation
  • Working knowledge of safety databases and their utilisation for the purposes of signal detection and aggregate report writing
  • An understanding of Medical Information and how this function may interact with the Benefit/ Risk team
  • Ability to author/ update SOPs or WINs
  • Ability to identify and author deviations/CAPAs
  • Knowledge of audit/ inspection process and participative experience
  • Experience in liaising with internal/ external stakeholders
  • Training/ mentoring experience

Main Responsibilities

  • Preparation, review and submission of Aggregate Reports (PSUR/ DSUR/ PADER/ ACO)
  • Authoring/ updating of RMPs
  • Creation/ maintenance of CCDSs and creation of supporting documentation (CO, CES, etc.)
  • Assistance with compilation of safety variations, if required
  • Assisting with responding to regulatory authority queries
  • Compilation and presentation of submission metrics for aggregate reports
  • Authoring of signal assessment reports
  • Assisting with scheduling and forecasting of aggregate reports and signal management activities
  • Assist senior team members and management in implementing and improving processes
  • Communication with internal and external stakeholders
  • Training/ mentoring new team members as necessary
  • Participating in internal/ external audits/ inspections as SME, if required
  • Assisting QMS team with deviations/ CAPAs, as assigned
  • Acting as Client Manager and back-up for clients and colleagues respectively, if required
  • Acting as a Local Representative for Pharmacovigilance in UK and Ireland
  • Assisting with any other ad-hoc requests, as necessary