Fortrea, a leading global contract research organization (CRO), is transforming drug and device development for partners and patients worldwide. With operations in over 100 countries and expertise in more than 20 therapeutic areas, Fortrea is now hiring for two critical roles: Safety Science Coordinator II and QA Controlled Docs Coordinator in Bangalore and Mumbai. If you’re passionate about clinical research and pharmacovigilance, this is your chance to join a team dedicated to delivering life-changing therapies.
Safety Science Coordinator II – Bangalore
Job Overview
The Safety Science Coordinator II will play a key role in managing clinical safety and pharmacovigilance operations. This includes processing adverse event reports, ensuring compliance with regulatory requirements, and supporting global safety reporting.
Key Responsibilities
- Process adverse event reports from clinical trials and post-marketing settings.
- Ensure timely submission of expedited safety reports to regulatory agencies and clients.
- Perform data entry, review, and coding of adverse events using MedDRA.
- Support quality reviews, database reconciliation, and audit preparation.
- Maintain compliance with SOPs, Work Instructions, and regulatory guidelines.
- Mentor and train junior staff as needed.
Qualifications
- 2-3 years of experience in pharmacovigilance or clinical trial case processing.
- Degree in Biological Sciences, Pharmacy, Nursing, or related fields.
- Strong attention to detail and excellent communication skills.
- Proficiency in MS Office and safety databases.
Why Join Fortrea?
Fortrea offers a collaborative work environment, opportunities for professional growth, and the chance to make a global impact in clinical research.
2. QA Controlled Docs Coordinator – Bangalore and Mumbai
Job Overview
The QA Controlled Docs Coordinator will ensure the administration and quality of controlled documents, supporting regulatory compliance and quality assurance processes.
Key Responsibilities
- Administer and maintain controlled documents for end-users.
- Perform quality checks and ensure timely escalation of issues.
- Support regulatory compliance and quality assurance activities.
- Complete day-to-day tasks with a focus on quality and productivity.
Qualifications
- Less than 1 year of experience in a similar role.
- Bachelor’s degree or equivalent experience.
- Strong organizational and communication skills.
- Attention to detail and ability to work well in a team.
Why Join Fortrea?
Fortrea values problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. Join us to be part of a team that’s revolutionizing drug development.
Why Fortrea?
Fortrea is a global leader in clinical research, providing innovative solutions to pharmaceutical, biotechnology, and medical device companies. With a commitment to scientific rigor and patient access, Fortrea is dedicated to accelerating the delivery of life-changing therapies.
