Functional Quality Associate II Job At Fortrea
Fortrea is hiring a Functional Quality Associate II for its Pune (Hybrid) location. The Pharmacy Job role involves quality review of safety reports, CAPA support, compliance checks, audit support, coordination with project teams, and regulatory submissions. Candidates with PV, safety writing, or quality review experience will excel in this high-impact position. Graduates seeking for Pharmacy Jobs and want to build their career in Pharmacy Careers can apply now.
Introduction of the Job
Fortrea is looking for a Functional Quality Associate II to ensure high-quality safety data review, compliance, process excellence, CAPA implementation, and support regulatory submissions. The Pharmacy Job position is Hybrid, based in Pune, with an application deadline of December 8, 2025.
About the Company
Fortrea is a global leader in clinical development and life sciences services, supporting pharmaceutical, biotechnology, and medical device clients worldwide. The company focuses on innovation, compliance, quality, and operational excellence. With advanced global capabilities in Pharmacovigilance, clinical operations, and regulatory support, Fortrea drives safe and effective healthcare solutions.
Educational Requirements for Pharmacy Job Role:
Bachelor’s/Master’s/PhD in:
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Pharmaceutical Sciences
Key Responsibilities for Pharmacy Job Role:
- Perform quality review of safety reports and maintain quality metrics.
- Identify trends, support client quality reviews, and contribute to CAPA preparation.
- Ensure CAPA implementation and maintain documentary evidence.
- Review safety reports, submission documents, labeling materials, PSURs, PADERs, CSR sections, CDS, USPI, SPCs, etc.
- Supporting functional quality operations involving adverse event processes, clinical/post-marketing data, and safety systems is required for Pharmacy Job
- Manage expedited AEs, product quality complaints, and medical information queries.
- Assist in training schedules, training material creation, and onboarding support.
- Participate in audit coordination and Quality Management Plan development.
- Supporting regulatory inspections alongside project teams is required for Pharmacy Job
- Suggest strategies for process improvement based on data analysis.
- Execute drug safety data processes, including call intake review and case documentation.
- Guide safety associates in managing voice calls when required.
- Track data, conduct QC checks, handle reconciliations, and maintain process excellence.
- Review safety reports for global submissions and ensure regulatory compliance.
Skills Required for Pharmacy Job Role:
- Strong knowledge of medical terminology & drug safety processes
- Knowledge of ICH, GCP, GVP guidelines
- Understanding of global regulatory safety submission requirements
- Case processing & assessment expertise
- Proficiency in MS Office
- Strong communication & analytical skills
- Ability to identify problems and take corrective action
Experience Required for Pharmacy Job Role:
- Minimum 2+ years in Pharmacovigilance, safety writing, CRO, biotech, or pharma
- Experience in peer review/quality review preferred
- Experience with quality metrics, CAPA reports, and AE documentation is an added advantage
How to Apply for Pharmacy Job Role:
Graduates seeking for Pharmacy Jobs and want to build their career in Pharmacy Careers can apply now directly through Fortrea’s official careers page before December 8, 2025.
