Are you a passionate professional with a background in pharmacovigilance and clinical safety? Fortrea, a leading global contract research organization (CRO), is hiring for the role of Safety Science Coordinator II in Bangalore. This is a full-time position with an application deadline If you have 2-3 years of experience in pharmacovigilance and a degree in biological sciences, pharmacy, nursing, or related fields, this could be the perfect opportunity for you. Read on to learn more about the job responsibilities, qualifications, and how to apply.
About Fortrea
Fortrea is a globally recognized CRO dedicated to advancing clinical development and delivering life-changing therapies to patients. With operations in over 100 countries, Fortrea provides comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. The company is committed to scientific rigor, innovation, and transforming drug and device development for its partners and patients worldwide.
Job Overview – Safety Science Coordinator II
As a Safety Science Coordinator II, you will play a critical role in managing and processing adverse event reports (AEs) from clinical trials and post-marketing settings. Your responsibilities will include ensuring compliance with regulatory requirements, maintaining accurate safety data, and supporting pharmacovigilance operations. This role requires attention to detail, strong communication skills, and the ability to work both independently and as part of a team.
Key Responsibilities
- Process adverse event reports from various sources, ensuring accuracy and completeness.
- Perform data entry of safety data into adverse event databases and tracking systems.
- Review and code adverse events using MedDRA, and write patient narratives.
- Ensure expedited reporting of serious adverse events (SAEs) to regulatory agencies, clients, and other stakeholders within specified timelines.
- Assist in the preparation and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain project files and documentation in compliance with Standard Operating Procedures (SOPs) and regulatory requirements.
- Support quality review, database reconciliation, and audit preparation activities.
- Mentor and train junior staff, contributing to team development.
- Liaise with clients and participate in client meetings as needed.
Qualifications and Experience
Minimum Requirements:
- 2-3 years of experience in pharmacovigilance or clinical trial case processing.
- Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related field.
- Strong attention to detail and accuracy.
- Excellent written and verbal communication skills.
- Proficiency in MS Office and Windows applications.
Preferred Qualifications:
- Experience in mentoring or training team members.
- Knowledge of global pharmacovigilance regulations and guidelines.
- Ability to work in a hybrid or office environment.
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 dedicated to overcoming barriers in clinical trials and accelerating the delivery of innovative therapies to patients in need.
