Drug Safety Associate Salary in Waltham, Massachusetts

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Average Salary for Drug Safety Associate in Waltham, Massachusetts

The average salary of a(n) Drug Safety Associate in Waltham, Massachusetts is $45,368.

The average hourly rate of a(n) Drug Safety Associate in Waltham, Massachusetts is $21.81.

The average bonus of a(n) Drug Safety Associate in Waltham, Massachusetts is $694.00.

Job Description:

Manages activities of case reports relating to the review, collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AE's) and serious adverse events (SAE's) for safety issues with marketed products and investigational compounds. Provides reconciliation of SAE's, coding, and data retrievals from the safety database. Reviews and evaluates AE case information to determine required action based on and following internal policies and procedures. Responds to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products. Interprets medical conditions, lab results, and procedures, and generates comprehensive, concise, accurate, and well-written narratives for all cases within the scope of responsibility. Ensures timely submission of reports to regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA are responded to in a timely manner. Defines necessary follow-up for these reports and assists in appropriate compliance with all regulatory agency reporting requirements. Identifies potential sources of product litigation, and extracts AE data from various clinical trial cases and spontaneous sources. Maintains the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process. Less

Manages activities of case reports relating to the review, collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AE's) and serious adverse events (SAE's) for safety issues with marketed products and investigational compounds. Provides reconciliation of SAE's, coding, and... More

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