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Life Sciences Jobs – Safety Science Coordinator Role
Join Fortrea as a Safety Science Coordinator II and play a vital role in ensuring patient safety and regulatory compliance across global clinical and post-marketing studies. Based in Bangalore, this full-time role at Fortrea careers offers professionals in life sciences the opportunity to manage adverse event reporting, support pharmacovigilance operations, and contribute to high-quality safety data processing within a collaborative, compliance-driven environment.
Job Details:
- Job Title: Safety Science Coordinator II
- Location: Bangalore
- Time Type: Full time
- Time Left to Apply: End Date: November 2, 2025 (5 days left to apply)
- Job Requisition ID: 25692
Safety Science Coordinator Role Overview:
Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post-marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual at Fortrea Careers.
About the Company:
Fortrea is a global Contract Research Organization (CRO) that partners with leading pharmaceutical and biotechnology companies to advance clinical research and drug development by offering various Biological Sciences Jobs. With a focus on quality, compliance, and innovation, Fortrea Careers provide end-to-end solutions in clinical development and pharmacovigilance, helping improve patient safety and healthcare outcomes worldwide.
Summary of Responsibilities for Safety Science Coordinator Role:
- In these Life Science Jobs, you have to process the adverse event reports from any source as per client/sponsor agreed plans.
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- Data entry of safety data onto adverse event database(s) and tracking systems; Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
- Write patient narratives and code adverse events accurately using MedDRA, if applicable to Determine lists against appropriate label (for Marketed products, if applicable).
- Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed.
- Ensure case receives appropriate medical review.
- Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines.
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines.
- Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to:
- Maintenance of tracking systems.
- Set-up and maintenance of project files and central files for documentation.
- Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required, within study specified timelines.
- Support with quality review or peer review of the processed reports.
- For this Life Science Jobs , you must assist and/or complete the database reconciliation and the associated activities, as applicable.
- Maintain study/project level documentation as per the agreed requirements, as applicable.
- Support with training of PSS staff and mentor the team as needed.
- Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed).
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting, and pharmacovigilance.
- Assist in the preparation for client meetings and liaise with client contacts, where appropriate.
- Assist in Quality issues management and support audit and inspection preparation, as needed.
- Ensure compliance of operations with governing regulatory requirements and applicable study/project plans and take responsibility for quality of data processed.
- Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any other duties as assigned by management.
- The above job duties are completed by the staff as applicable, depending on the role they are assigned to.
Qualifications Required for Safety Science Coordinator Role:
- 2 – 3 years relevant experience.
- Experience in clinical trial case processing is preferred
- Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Experience Required for Safety Science Coordinator Role:
- High degree of accuracy with attention to detail.
- Functions as a team player and offer peer support as needed.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good keyboard skills with knowledge of MS Office and Windows application would be beneficial.
- Mentoring skills preferred.
Work Environment:
Office Environment or hybrid.
How to Apply?
Eligible candidates can apply through the official Fortrea Careers Portal. Ensure your resume highlights relevant pharmacovigilance and clinical safety experience. Applications close on November 2, 2025.
