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Drug Safety Systems Specialist

  • Job type: Permanent
  • Location: North Carolina
  • Salary: $100000 - $120000 per annum
  • Job reference: ARTR111317
  • Sector: Clinical, EPM Scientific
  • Date posted: 13/11/2017
Drug Safety Systems Specialist
  • Drug Safety Systems Specialist
  • Raleigh-Durham, NC
  • Competitive salary + excellent bonus + excellent benefits
A well established oncology focused biopharmaceutical company is looking for a Drug Safety Systems Specialist to join their rapidly expanding team! This company has a strong pipeline, with many indications in later stages of clinical trials on track to be approved by the FDA.
Now is a pivotal time to get in with this group as the Drug Safety Systems Specialist as there are tremendous amounts of opportunities for professional growth within the company.
The Drug Safety Systems Specialist will have the following responsibilities:
Reporting to the Director, Pharmacovigilance, the Drug Safety Systems Specialist will be responsible for the support and administration of primarily the Argus Safety System, and will manage safety data from clinical and post marketed adverse events reports within the company’s central safety database. Supporting key processes ensure efficient maintenance of the PV configuration of the system.
  • Support the design and implementation of applications to sustain Global PV objectives, including Argus Safety database, MedDRA, PVQ, Empirica, etc.
  • Support programming, validation, and generation of reports for data analysis, including US periodic reports (e.g., PADER, Annual) and ICH PSUR/PBRER line listings.
  • Support with validation and troubleshooting of Argus Safety Suite
  • Interpret regulatory changes as they impact technology and provide technical expertise to implement regulatory changes for maintaining compliance.
  • Update and review training documentation for global PV SOPs related to Argus database and data management
  • Support MedDRA version management and upgrades as required by the Safety System Manager and departmental procedures
  • Manage and compile key drug safety case processing and resource requirement metrics, as well as aggregate safety reporting metrics
  • Support the resolution of complex, cross-functional issues using strong problem-solving abilities
The ideal candidate will have the following skill set:
  • Education: Minimum of B.S. (R.N. Preferred)
  • 2 + years drug safety experience
  • At least 2 years of experience in Oracle Argus Safety Suite