Drug Safety Associate Job

Yoh has a great six (6) month contract opportunity for a DRUG SAFETY ASSOCIATE to join our client in Dublin, CA.

JOB OVERVIEW:

Our client is currently seeking a qualified candidate to work as Drug Safety Associate. The Drug Safety Associate (Contract) is responsible for managing activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for pharmaceutical products.

JOB RESPONSIBILITIES:

- Responsible for processing individual case safety reports (ICSR), particularly serious adverse event (SAE) reports, and distributing to appropriate internal and external parties according to SOPs and local/international regulations within the specified timelines
- Demonstrate knowledge of safety concepts (FDA, ICH, EMEA, and other international guidelines) by application to daily functions
- Participate in the case review process applying a high standard of quality review to ensure sound medical safety data documentation
- Perform all data entry and administrator functions required for the safety database
- Provide coverage for SAE handling and other essential department functions during non-business hours, weekends, and holidays according to department-defined basis
- Identify and initiate requests for case follow up for ICSRs
- Participate in the development/revision of MedDRA Coding Conventions
- Support the project team in the preparation of all customized and other regulatory safety reports. (eg, Annual Reports, cumulative SAE reports, safety database reports)
- Assist in the SAE reconciliation according to study requirements
- Contribute to the development and review of safety related documents including study protocols, safety data collection formsvisit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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