Safety Science Coordinator II

2 weeks ago


pune, India CSS Fortrea Scientific Pvt Ltd Full time

Description

• Receive/identify a suspected ADR/ADE report from, but not limited to, the following sources: directly via mail/ telephone/ fax/ email, Client employee, published literature.
• Perform duplicate check, verify & record the following dates, and record in compliance to client requirements.
• Acknowledge via e-mail, fax, telephone call or mail receipt of the ADR/ADE report.
• Create a new case entry in Safety database as per client SOPs/WI in case of a valid case.
• Perform relevant documentation in compliance to client requirements.
• Perform reconciliation of data from multiple sources including literature search and literature citation review
• Perform complete data entry and medical coding of all available data in the relevant safety database.
• Initiate follow-up with reporter as per the client SOPs/WI
• Compile case narrative in accordance with the Client Narrative Composition Guidelines
• Perform review of safety reports to ensure data has been entered.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.



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