Pharmacy Job at Fortrea | Apply Now for the Safety Science Coordinator Role
Fortrea is hiring a Safety Science Coordinator II to support global pharmacovigilance and clinical safety operations. In this role, you will manage adverse event processing from clinical trials and post-marketing sources, ensure regulatory compliance, and deliver high-quality safety data for clients worldwide. This Pharmacy Job is a great opportunity for professionals looking to grow in safety operations, case processing, and regulatory reporting within a fast-paced CRO environment.
- Job Title: Safety Science Coordinator II
- Location: Bangalore
- Job Requisition ID: 25692
About the Company
Fortrea is a leading provider in clinical research and related services, dedicated to assisting our clients with high-quality clinical safety and pharmacovigilance operations. Our team works diligently to ensure safety data from clinical trials and post-marketing settings are handled with care, precision, and efficiency.
Fortrea Job Overview
Assist with the overall Clinical Safety and/or PSS operations associated with products, including the adverse events process. Manage and process expendable adverse events to the required standard and submit them to the client and regulatory agencies within the agreed timelines. Ensure compliance with legal requirements and provide clients with appropriate quality of service.
Responsibilities of the Fortrea Job
- Process adverse event reports from any source as per client/sponsor agreed plans.
- Manage receipt and processing of all adverse event reports, including data entry, review for completeness, and expedited reporting.
- Write patient narratives and code adverse events using MedDRA.
- Identify missing information and generate queries for collection.
- Ensure medical review and prioritize cases needing expedited reporting.
- Submission of expedited SAE reports and assistance with ESRs and PSRs.
- Support quality review, database reconciliation, and maintain study documentation.
- Assist with training, prepare for client meetings, and manage quality issues.
- Ensure compliance with regulatory requirements and project plans.
Qualifications (Minimum Required)
- 2 – 3 years of relevant experience.
- Degree in Pharmacy or related area preferred.
- Experience in clinical trial case processing is preferred.
Experience (Minimum Required)
- High degree of accuracy and attention to detail.
- Team player with good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Proficient in MS Office and Windows applications.
- Mentoring skills preferred.
Work Environment
Office Environment or hybrid.
