Life Science Jobs at Fortrea | Hiring for Functional Quality Associate Role | Apply Now
Looking for impactful life science jobs in pharmacovigilance with global exposure? Join Fortrea as a Functional Quality Associate II , a role central to drug safety, quality review, and regulatory compliance. If you’re ready to advance your Fortrea career and contribute to the safety of medicines worldwide, this opportunity offers challenging work, continuous learning, and a chance to grow in the pharmaceutical industry.
- Job Title: Functional Quality Associate II
- Location: Pune
- Job Requisition ID: 255866
About the Company
Fortrea is a globally recognized contract research organization (CRO) specializing in clinical research, drug development, and pharmacovigilance services. With a strong commitment to safety, quality, and regulatory excellence, Fortrea supports clients worldwide in ensuring that medicines and therapies meet the highest standards. For professionals searching for Pharmacovigilance jobs or life science jobs, Fortrea represents a dynamic workplace offering growth, global exposure, and meaningful impact on patient safety and healthcare outcomes.
Key Responsibilities
1. Quality Review & Safety Reporting
- Perform quality review of safety reports
- Review expedited adverse events, product quality complaints, medical information and general queries (via call, email, fax)
- Review samples of cases for global regulatory submissions, labeling/regulatory documents, clinical study reports, safety update reports (IND, PSUR, PADER), Core Data Sheets, USPI, central SPCs, MedGuides, etc.
2. Regulatory Compliance & Documentation
- Assist in preparation of corrective and preventive actions (CAPA) and ensure their implementation with documented evidence
- Contribute to Quality Management Plans and client audits/inspections support
- Ensure compliance with ICH, GCP, GVP and other relevant international regulatory guidelines
3. Process Improvement & Quality Metrics
- Compile quality metrics, analyze trends, and assist in periodic client quality reviews
- Design and track training schedules/materials for new hires and the existing team
- Participate in discussion forums on quality errors and propose process improvements
4. Support & Coordination
- Manage safety data processes: call intake review, documentation, case follow-up
- Support project teams in audits or regulatory inspections as needed
- Provide cross-functional communication and share business information across departments
Educational Requirements
- Bachelor’s / Master’s / PhD in Life Sciences, or related biological sciences
- 2+ years of experience in the pharmaceutical, biotechnology, or CRO industry, preferably in pharmacovigilance, safety writing, peer review or quality review
Skills Required
- Strong understanding of pharmacovigilance, safety reporting, and regulatory requirements (ICH, GCP, GVP)
- Proficient in medical and drug terminology
- Excellent documentation, quality review, and analytical skills
- Ability to identify problems, take corrective action, and work under compliance standards
- Good communication, coordination, and cross-functional collaboration skills
- Competent with Microsoft Office and data management tools
- Preferred: Experience generating quality metrics, CAPA reports, and peer-reviewed safety documentation.
If you are seeking fulfilling pharmacovigilance jobs with scope for growth and global impact, this Life Science Jobs opportunity at Fortrea is ideal for you. As a Functional Quality Associate II, you’ll contribute to drug safety and regulatory compliance — building a strong Fortrea career while enhancing patient safety worldwide. Don’t miss this chance to join a leading CRO and make a difference
