Job Description

Stamford, CT


Contract Duration: 12-36 months


Rate: Negotiable


Salary: NA, $1.00

• 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

• 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

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