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Senior Safety Data Analyst

2 months ago

Pune, India Fortrea 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.

Job Summary:

Assist with the overall ISR operations associated with the set-up, planning, and maintenance. The post holder is responsible for supporting team members in providing this service to Sponsor-Investigators either as a support function to the project groups. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Essential Job Duties:

Manage the set-up, planning, and maintenance of ISRs projects in the ISR Portal Maintain a strong understanding of BMS’s ISR conventions or client specific database conventions, as appropriate Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided Support/train/mentor less experienced safety staff in all aspects of ISRs Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with ISR Participate in ISR project team and internal meetings, as appropriate Prepare and support coordination of ISR study files for archiving at completion of projects Any other duties as assigned by management

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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