Benefit-Risk Scientist: Pharmacovigilance

Job Title: Benefit/ Risk Scientist, Pharmacovigilance Benefit/Risk Team
Reports to: Benefit/Risk Team Lead, Pharmacovigilance
Location: Dublin or Harlow
Contact: careers@diamondpharmaservices.com

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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.

Skills

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

Required:

• 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

Desired:

• 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