Senior Safety Associate

3 weeks ago

Smyrna, United States Randstad Sourceright Full time

NATURE & SCOPE

Under supervision of the Head of US Safety, the individual is responsible for contributing to daily activities to ensure a compliant Pharmacovigilance (PV) system in order to safeguard public health and maintain compliance with applicable regulatory requirements.

Including but not limited to is daily monitoring of the shared drug safety mailbox, proper review of individual case safety reports (ICSRs) and proficient oversight over the service provider for safety case intake; Quality Checks on local deliverables (i.e. ICSRs); assisting the US Safety team with local PV deliverables as required; provide project support as required


MAJOR ACCOUNTABILITIES

  • Supporting routine Pharmacovigilance Operations
  • Responsible for appropriately monitoring and managing the US Drug Safety affiliate mailbox, supporting the affiliate PV service provider as required to ensure all ICSR information is processed in timely manner
  • Responsible for reviewing non-valid cases identified by PV service provider and providing final approval for case validity in such instances
  • Review of service provider trackers as required per procedures
  • Perform Quality Check of ICSRs/electronic submissions or other US Safety deliverables in accordance with UCB internal procedures and providing feedback to appropriate stakeholders as required
  • Independently address queries raised by affiliate and case processing teams in accordance with internal procedures
  • Liaise with marketing team project/program owners to ensure proper documentation is in place, in accordance with SOPs, for programs with Pharmacovigilance impact, and ensure timely updates to the various tracking tools
  • Provide support in reviewing workflows, Standard Operating Procedures, Working Practices and other Guidance Documents
  • Provide Pharmacovigilance Training to vendors/in house personnel as required.
  • Support with proper archival of US Safety documentation/forms
  • Maintain current knowledge of drug safety regulations and procedures
  • Other responsibilities and projects as assigned by manager/company


Education

Bachelor's degree - required


Experience

  • Education in a health-related area highly preferred as well as basic knowledge with the medical terminology.
  • Minimum 3 years of Pharmacovigilance Experience, preferentially with ICSR processing
  • Good understanding of Pharmacovigilance and related obligations


Specific skills

  • Creative and persistent problem solver. Recognize areas of process improvements related to the function and provide feedback to management
  • Takes ownership of meeting high standards
  • Ability to prioritize, organize and plan
  • Proficiency with safety databases, MS office applications
  • Ability to network and effectively communicate with international teams


Problem solving

  • Proactive and independent problem solver
  • Quality oriented
  • High level of creative and innovative thinking

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