United BioSource Corporation.

Safety Data Manager

Location
Blue Bell, US
Salary
Competitive
Posted
04 Mar 2021
Closes
03 Apr 2021
Ref
2743
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)


Brief Description:
  • Maintains configuration documentation
  • Lead the configuration of new programs on the Argus System
  • Support the change management for existing programs on the Argus System
  • Maintains Configuration documentation for the Argus System
  • Configure and verify ad-hoc reporting out of the Argus System
  • Modifying PV systems for optimal workflow and production, and participating in the implementation of IT solutions
  • Support the Safety Managers, Data Associates and Safety Scientists when required.
  • Provide support and ensure collaboration during the upgrade process, i.e. installation, validation and implementation of the Argus System version.


Requirements:
  • Minimum of a bachelor’s Degree and/or 5 years Safety Data experience
  • Fluent in English; additional languages a plus, but not required
  • Strong computer skills
  • Computer science knowledge preferred, but not mandatory
  • Clinical Research experience preferred, but not mandatory
  • Drug safety regulated environment working experience preferred
  • Minimum of a bachelor’s Degree and/or 5 years Safety Data experience
  • Strong computer skills with Argus experience; i.e. configuring Argus programs, creating periodic and ad-hoc reports
  • Good knowledge of GXP, ICH guidelines and of reporting requirements to Regulatory Agencies


Specific Job Duties:
  • Safety database administration
  • Actively participate in the management of the installation, validation and configuration of Safety Database
  • Conduct validation activities on project specific configurations
  • Perform quality control on entered cases to ensure cases meet highest standards
  • Support and educate to safety database end users and sponsors, if applicable
  • Support the Safety Managers/Safety Scientists/Safety Data Associates
  • Assist in the reconciliation process for all safety programs
  • Enter data into safety database with accuracy
  • Ability to effectively communicate with both technical and non-technical individuals
  • Inspect and resolve safety database problems quickly and effectively
  • Be aware of and maintain the workflow and timelines for each project


ABOUT UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visiting

www.ubc.com

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