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Job Details

Drug Safety Scientist (Safety Writing Team)

Company: United BioSource Corporation.
Location: Geneva, Switzerland
Reference: 16000042
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, 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, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines. 
 
Specific Job Duties:

Assist with the preparation of Adverse Event Reporting Plans (AERPs)
Alert Project Management when activities fall outside SOW
Process and evaluate Adverse Event reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating 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
Medical review 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
 
Requirements:

Registered Nurse, Pharmacist, or other health care professional degree
Comprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketing
Experience in pre and post marketing Pharmacovigilance
Experience with case narrative writing for Adverse Event Reports
Experience in the review and analysis of the literature output
Experience in PV regulatory reporting activities
Knowledge of database management and use of coding dictionaries
Fluent in English, additional language fluency a plus, but not required
 
Supervisory Responsibilities:

Ensure time management and assess quality of work
Ability to provide constructive feedback for performance improvement when appropriate

NO AGENCIES PLEASE

Apply for this job: Drug Safety Scientist (Safety Writing Team)

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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