Benefit Risk Scientist - Pharmacovigilance - CRO

Location
Dublin (City), Leinster (IE)
Salary
45,000
Posted
12 Jan 2021
Closes
11 Feb 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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 djolley@compassltd.co.uk      
     
Recommendations      
       
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     
     

Apply for Benefit Risk Scientist - Pharmacovigilance - CRO

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs