Are you a passionate professional with 3-4 years of safety experience in the pharmaceutical or clinical research industry? Fortrea, a leading global contract research organization (CRO), is hiring a Safety Science Specialist for its Bangalore office. This is a full-time position with an application deadline of March 21, 2025. If you are looking to advance your career in clinical safety and pharmacovigilance, this is your opportunity to join a company dedicated to transforming drug and device development worldwide.
About Fortrea
Fortrea is a trusted name in the clinical research industry, providing comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in approximately 100 countries, Fortrea is committed to delivering innovative solutions to pharmaceutical, biotechnology, and medical device companies. Their mission is to accelerate the delivery of life-changing therapies to patients in need.
Job Overview: Safety Science Specialist
As a Safety Science Specialist, you will play a critical role in managing and processing adverse event reports, ensuring compliance with global regulatory requirements. This position involves handling safety data from clinical trials and post-marketing settings, including expedited reporting to regulatory agencies and clients. You will be responsible for maintaining the highest standards of safety and quality while adhering to Fortrea’s Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Key Responsibilities
- Manage the receipt and processing of adverse event reports from clinical trials and post-marketing sources.
- Perform data entry of safety data into adverse event databases and tracking systems.
- Review adverse events for completeness, accuracy, and expedited reporting requirements.
- Write patient narratives and code adverse events using MedDRA.
- Ensure timely submission of expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, and other stakeholders.
- Assist in database reconciliation and the preparation of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Support root cause analysis and CAPA plan development for quality issues.
- Participate in audits, inspections, and client meetings as required.
- Maintain compliance with global pharmacovigilance regulations and Fortrea’s safety management protocols.
Qualifications and Requirements
- 3-4 years of experience in pharmacovigilance, clinical safety, or a related field.
- Strong knowledge of MedDRA coding and adverse event reporting.
- Familiarity with global regulatory requirements for pharmacovigilance.
- Excellent attention to detail and organizational skills.
- Ability to work in a fast-paced, deadline-driven environment.
- Strong communication and interpersonal skills.
- Job Location: Bangalore (Office-based).
Why Join Fortrea?
Fortrea is committed to fostering a diverse and inclusive workplace where employees can thrive. As an Equal Opportunity Employer, Fortrea values diversity and does not discriminate based on race, religion, gender, age, disability, or any other legally protected characteristic. By joining Fortrea, you will be part of a team that is passionate about overcoming barriers in clinical trials and delivering innovative solutions to improve patient outcomes.
