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Safety Scientist- 9 months contract

Entreprise
UBC
Lieu
Genève (Rive droite)
Date de publication
22.11.2016
Référence
236914

Description

ABOUT UBC Europe
United BioSource Corporation (UBC) is the leading provider of integrated development and commercial support solutions that deliver evidence of safe use, while optimizing access to mediation and care.


UBC leverages our specialty pharmacy therapy expertise and contracts for specialty pharmacy and specialty distribution services. 


UBC's services include reimbursement, patient assistance and alternate funding programs, channel optimization through specialty pharmacy, specialty distribution and 3PL services, Customized clinical adherence and commercialization strategies powered by Express Scripts data.

Safety Scientist- 9 months contract

Responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, Individual Case Safety Report (ICSR) case processing, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines. 

Specific Job Duties:


•Writing of procedural documents such as Adverse Event Reporting Plans (AERPs)

•Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness and causality assessment

•Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings

•Assist in the reconciliation of clinical and safety databases

•Monitor compliance and ensure appropriate documentation (metrics, deviations)

•Assist in evaluation and validation of systems to support safety e.g. supporting the development teams in safety database configuration and EDC specifications

•Performing global and local literature review

•Project oversight and identification of issues. Escalation.


Requirements:


•Registered Nurse, Pharmacist, or other Life - Science degree

•Comprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketing

•Experience in pre and post marketing Pharmacovigilance

•Experience in literature review

•Experience in case processing and PV regulatory reporting activities

•Experience in data entry in ICH E2B compliant database

•Knowledge of database management a plus

•Fluent in English, additional language fluency a plus, but not required



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