Safety Specialist

Department

Global Safety

Location

Berwyn, PA

Summary

Responsible for management, processing and reporting of adverse events in compliance with REGISTRAT-MAPI and project specific SOPs and applicable regulatory authorities. Provide support for the clinical services business area as part of the clinical services team.

Requirements

Candidate must have an R.N., B.S.N., Pharm.D., M.S.N., or other health-related degree with at least 3-5 years' relevant industry/clinical experience, preferably in drug safety, including CRA experience with an understanding of the SAE processing environment in which drug safety operates, knowledge of experience with regulatory adverse event reporting requirements, computer proficient and outstanding writing skills.

Responsibilities

  • Perform data entry/verification of event in safety database
  • Determine classification of AE
  • Follow-up with sites to collect supporting documents
  • QC data entry with supporting documentation
  • Code adverse events
  • Prepare and QC case narratives
  • Prepare safety reports and summaries for manufacturers and regulatory authorities
  • Assist with reconciliation of clinical and safety databases
  • Prepare and report adverse events in compliance with applicable regulations of international regulatory authorities
  • Prepare and report adverse events in compliance with REGISTRAT-MAPI and project specific safety SOPs
  • Review, revise, and develop new (as applicable) SOPs for safety processing and reporting
  • Provide suggestions for enhancements to REGISTRAT-MAPI safety system
  • Serve as a resource to internal departments, sponsors, and for business development purposes
  • Assist with clinical development functions (e.g., protocol and CRF development)
  • Provide support in the area of new business RFP evaluation and presentation of company capabilities to potential clients
  • Assist in the development of the clinical services area by serving in initiatives designed to improve the quality and composition of our services
  • Travel may be required for client and potential client meetings

To contact Human Resources please click here. Or, feel free to contact us at:

REGISTRAT-MAPI
2343 Alexandria Drive, Suite 400
Lexington, KY 40504.3276
Tel: 859.223.4334
Fax: 859.514.4350