Drug Safety Associate

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 Fladger Associates