Benefit-Risk Scientist: Pharmacovigilance
Job Title: Benefit/ Risk Scientist, Pharmacovigilance Benefit/Risk Team
Reports to: Benefit/Risk Team Lead, Pharmacovigilance
Location: To be decided
Contact: careers@diamondpharmaservices.com
Click here to download the job description
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