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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