Functional Quality Specialist II
Location: Pune
Category: Clinical
Job ID: 25567
Company: Fortrea
Company Overview
Fortrea is a global contract research organization (CRO) providing pharmaceutical, biotechnology, and medical device clients with comprehensive clinical development, regulatory, and patient access solutions. Operating in nearly 100 countries, Fortrea is dedicated to advancing scientific innovation and accelerating drug development.
Role Overview
The Functional Quality Specialist II will be responsible for ensuring high-quality service delivery across clinical and regulatory projects. This role involves reviewing quality metrics, assisting in client quality reviews, supporting regulatory submissions, managing adverse event reports, and driving process improvements.
Key Responsibilities
Quality Review & Compliance
Take ownership of assigned quality reviews on projects.
Compile quality metrics and identify trends.
Assist in addressing periodic client quality reviews and ad-hoc findings.
Prepare initial drafts of Corrective and Preventive Actions (CAPAs).
Perform ongoing reviews of regulatory safety reports and documents, including:
Annual Reports (IND and other)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Clinical Study Reports (CSRs)
Core Data Sheets, USPI, SPCs, Med Guides
Safety & Adverse Event Management
Support functional quality operations related to adverse events from clinical trials and post-marketing data.
Manage and review:
Expedited adverse events
Product quality complaints
Medical information queries
Ensure timely submission of reports to clients and regulatory agencies.
Process Improvement & Training
Take ownership of assigned CAPAs, ensuring timely closure with supporting documentation.
Contribute to process reviews, identifying improvements and best practices.
Assist in designing and tracking training schedules and training material.
Initiate discussion forums on quality errors and process enhancements.
Audit & Regulatory Support
Coordinate and support client or external audits of assigned projects.
Draft sections of the Quality Management Plan for assigned projects.
Work with the project team to support clients during regulatory inspections.
Implement and promote consistent, efficient, and quality processes.
Data Management & Analysis
Respond to medical information queries and product quality complaints received via phone, email, or fax.
Execute drug safety data management processes, including case intake, documentation, and follow-ups.
Guide safety associates in managing voice calls when needed.
Track various types of data, conduct quality control, and perform reconciliation of information.
Conduct data analysis and suggest strategies for process improvement.
Other Responsibilities
Perform any additional duties as assigned, ensuring regulatory compliance and quality excellence.
Required Experience & Skills
Experience in Quality Assurance, Regulatory Compliance, or Pharmacovigilance in a clinical research or pharmaceutical setting.
Knowledge of global regulatory requirements for clinical trials and drug safety.
Familiarity with GxP, ICH-GCP, safety data management, and regulatory submission processes.
Strong analytical and problem-solving skills.
Ability to work independently and manage multiple quality initiatives.
Excellent written and verbal communication skills.
Experience in process improvement, CAPA management, and training coordination.
About Fortrea
Fortrea is committed to advancing clinical trials and enhancing patient access through innovation and collaboration. We offer a dynamic and inclusive work environment where professionals can drive meaningful global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and is committed to diversity and inclusion. We do not tolerate discrimination or harassment based on race, religion, gender, disability, veteran status, or any other legally protected characteristic.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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