Fortrea, a global leader in clinical research and drug development, is hiring
Safety Science Specialists in Bangalore, India. This role offers an exciting opportunity for professionals with expertise in pharmacovigilance and clinical trial case processing. If you have over 3 years of experience in adverse event management and safety reporting, Fortrea provides the ideal platform to advance your career in a dynamic and impactful industry.
About Fortrea
Fortrea is a leading contract research organization (CRO) known for its dedication to scientific rigor and clinical development. With over 19,000 employees operating across 90 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to bring life-changing therapies to patients worldwide. Fortrea focuses on transforming clinical trials through innovative solutions and ensuring patient safety.
Job Role: Safety Science Specialist
As a
Safety Science Specialist at Fortrea, you will be responsible for managing adverse event reports, ensuring timely submission of safety data, and collaborating with various stakeholders to ensure regulatory compliance. This full-time role is based in Bangalore, India, and plays a critical role in maintaining patient safety during clinical trials.
Key Responsibilities
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited 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, Code adverse events accurately using MedDRA.
- Determine listedness against appropriate label (for Marketed products, if applicable)
- Identifies clinically significant information missing from the reports and ensures its collection; Prepare follow-up correspondence in consultation with the medical staff, as needed.
- Ensure case receives appropriate medical review.
- Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines.
- Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, 3rd party vendor, Partner and Fortrea project personnel, if required, within study specified timelines.
- Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines.
- Assist or contribute to Database reconciliation in liaison with Data Management team or clients.
- Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, includes but not limited to:
- Maintenance of adverse event tracking systems
- Set-up and maintenance of project files and central files for documentation
- Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines.
- Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed.
- Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Assist in the generation and maintenance of the PSS metrics.
- Support preparation for client meetings and liaise with clients where appropriate.
- Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable.
- Prepare and support coordination of safety study files for archiving at completion of projects.
- Support Root cause analysis and CAPA plan development for the identified quality issues, as needed.
- Support and/or participate in audits and inspections including the preparation, as needed.
- Demonstrate role-specific Core Competencies and company values on a consistent basis ¨ Build and maintain good PSS relationships across functional units.
- All other duties as needed or assigned.
Qualifications
- Minimum 3+ years of experience in pharmacovigilance, specifically in clinical trial case processing.
- Knowledge of adverse event reporting, safety database management, and regulatory timelines.
- Proficiency in MedDRA coding and preparation of patient narratives.
- Strong attention to detail and ability to manage multiple timelines and reports.
- Excellent communication skills and the ability to work collaboratively within cross-functional teams.
- Knowledge of SOPs and Standard Operating Procedures related to pharmacovigilance and safety management.
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Job Location
- Location: Bangalore, India (On-site)
How to Apply
Interested candidates can apply for the
Safety Science Specialist position by visiting
Fortrea’s career page
https://pharmastuff.org.in/job/fortrea-safety-science-specialist
