Compass Life Sciences are partnered with a market leading specialist consultancy and CRO working across a wide variety of sectors and Pharma companies. With supported products varying from COVID19 vaccines through to end-to-end PV support for Gene therapy, this is an incredibly exciting and diverse company with excellent prospects.
Due to an ever-expanding portfolio and the increased general demand across the life science sector, our client is now actively seeking a Benefit Risk Scientist to support the current PV team and ensure compliance throughout all aspects of Pharmacovigilance.
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
REQUIREMENTS
To be considered for this role our client is looking for candidates that have a thorough foundation in Pharmacovigilance, with a broad experience across the field. You should be able to demonstrate significant experience in authoring and reviewing aggregate reports including PSURs, PADERs, DSURs, and ACOs in line with applicable templates and regulations.
In addition to this our client is looking for the following key skills and experience;
- 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
Ideally you will also be able to demonstrate a strong knowledge of Pharmacovigilance processes including ICSR processing, QC, literature searching, XEVMPD, and PSMF creation. A knowledge of safety databases and their utilisation with signal detection and aggregate report writing is desirable. Also an understanding of Medical Information and how this function may interact with the Benefit/ Risk team along side the ability to author / update SOPs or WINs, identification and authoring deviations/CAPA, and knowledge of audit / inspection processes is ideal but not essential as you will be given training and exposure to these in role.
This is role offers a fantastic opportunity to the right applicant, with great potential for development and promotion within an exciting company who are rapidly expanding across all Pharma sectors.
If you wish to apply, please contact David Jolley on +44 (0) 2393877358 or at [email protected]
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Compass Associates Ltd. trading as Compass Life Sciences are acting as a Recruitment Consultancy for this permanent vacancy; we offer £/€200 worth of Amazon Vouchers for each successful recommendation
