Company Overview:
Fortrea, a leading global contract research organization (CRO), is dedicated to scientific excellence and boasts decades of clinical development experience. We offer a comprehensive suite of clinical development, patient access, and technology solutions across over 20 therapeutic areas. With a team of more than 19,000 professionals operating in over 90 countries, Fortrea is at the forefront of transforming drug and device development for partners and patients worldwide.
Job Description:
As a key member of our team, you will:
Adverse Event Management: Oversee the receipt and processing of all adverse event reports from various sources, including spontaneous reports and clinical trials. This involves:
Regulatory Compliance: Process cases requiring expedited reporting to regulatory agencies and other relevant parties within required timelines. This includes:
Database and Documentation Management: Contribute to database reconciliation with Data Management teams or clients. Manage the processing of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including:
Quality Assurance and Support: Perform quality reviews or peer reviews of processed reports. Support the Line Management with trend analysis and necessary actions. Maintain a thorough understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), and pharmacovigilance guidelines. Assist with preparation for client meetings, safety committees, and study file archiving.
Additional Duties: Support root cause analysis, CAPA plan development, and participate in audits and inspections as needed. Build and maintain strong relationships across functional units and perform other duties as assigned.
Experience Required:
Job Location:
Bangalore, India.
Why Join Us:
Fortrea is seeking motivated problem-solvers and creative thinkers who are passionate about advancing clinical trials. We are committed to revolutionizing the development process to deliver life-changing therapies to patients efficiently. Join our collaborative and growth-focused team to make a meaningful global impact.
For more information about Fortrea, visit www.fortrea.com.
Equal Opportunity Employer:
Fortrea is an Equal Opportunity Employer. We are dedicated to diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender, sexual orientation, gender identity, disability, or any other legally protected characteristic. We encourage all qualified individuals to apply.
For details on how we handle your personal data, please review our Privacy Statement.
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