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Job Details

UBC - Safety Scientist

Company: United BioSource Corporation.
Location: Geneva, Switzerland; London, United Kingdom
Reference: 16000040
Closing Date: 05 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package

Job Summary:

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

Requirements:

Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.

Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.



Brief Description:
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

NO AGENCIES PLEASE

Apply for this job: UBC - Safety Scientist

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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