Safety Science Coordinator II

📍Pune India

Contents

Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe
Job 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.