Drug Safety Associate Job at Fladger Associates, Stamford, CT

  • Fladger Associates
  • Stamford, CT

Job Description

Stamford, CT


Contract Duration: 12-36 months


Rate: Negotiable


Salary: NA, $1.00

Responsibilities:

  • Excellent employment opportunity for a Drug Safety Associate in the Stamford, CT area.
  • Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
  • Preparation of SUA summary: Analysis of Similar Events
  • Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
  • Liaison with Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
  • Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
  • Processes & procedures: awareness of and input to company procedures and guidance
  • Completion of all assigned training on company and GMSO procedural documents relating to case processing
Experience:
  • Health/Biomedical Degree BS
  • Minimum 5 years of experience in pharmaceutical safety-related role
  • Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred

Job Tags

Contract work

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