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Job Details

UBC - Safety Scientist

Company: United BioSource Corporation.
Location: Geneva, Switzerland; London, United Kingdom
Reference: REQ20005244
Closing Date: 11 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package

Job Summary:

This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; global and local literature review; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training, mentoring and contributing to the...

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:
This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; global and local literature review; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training, mentoring and contributing to the development and maintenance of departmental standards (SOPs) and guidelines. 
 
Specific Job Duties:

  • Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required
  • Review project specific proposals, pricing and protocols to ensure consistency within the AERP
  • Maintain oversight of all administrative changes and updates
  • Ensure compliance with project specific processes and SOPs
  • Alert Project Management when activities fall outside SOW or documented processes
  • Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness 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
  • Maintain oversight of case workflow; act as Workflow Manager for specific projects
  • Actively engage in gap analysis for SOPs and guidance documents
  • Preparation of training materials specific to safety, participate and/or lead training sessions
  • Assist in the reconciliation of clinical and safety databases
  • Contribute to the preparation and quality control of responses to authorities, company core data sheets, signal detection and assessment
  • Perform literature review for identification of case reports and other relevant safety information
  • Collaborate with Management to update or design project process improvements
  • Liaise with both internal and external vendors (clients, patients and HCPs)
  • Review/Quality Check (QC) of source documents, coding, data entry, report generation and distribution
  • Monitor compliance metrics and ensure appropriate documentation when deficient.
  • Assist in evaluation and validation of systems to support safety

Supervisory Responsibilities:

  • Lead project teams
  • Train and mentor personnel assigned to project teams

Requirements:

  • Registered Nurse, Pharmacist, or other degree in a Life Science-related field
  • Knowledge of ICH, EMA and FDA Regulations and Guidelines both clinical and post marketing pharmacovigilance and clinical safety
  • Prior experience in CRO/Pharma/Biotech safety department, minimum 3 years
  • Knowledge of vaccine and medical device reporting requirements, a plus
  • Proficient with case review, extrapolation and composition of ICSR narratives and causality assessment
  • Proficient with computer programs (Safety database, Word, PowerPoint, Excel)
  • Good communication, interpersonal interaction, project management and organizational skills are essential
  • Fluent in English, additional language fluency a plus, but not required

*LI-AF1-UBC

 


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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