Fortrea is hiring a Specialist I, Process Compliance Review and Analysis in Pune. This role is ideal for professionals with 2+ years of experience in pharmacovigilance, safety writing, and quality review within the pharmaceutical, biotechnology, or CRO sectors. The position focuses on ensuring high-quality service delivery, regulatory compliance, and process excellence in global safety reporting and documentation.
This opportunity is perfect for candidates looking to enhance their expertise in GCP, GVP, ICH Guidelines, and global regulatory requirements while contributing to corrective and preventive actions (CAPA) and quality metrics.
Advertisement
Key Responsibilities
- Perform quality review of safety reports, clinical study reports, and regulatory documents for Fortrea clients.
- Compile and analyze quality metrics to identify trends and drive process improvements.
- Assist in preparation and implementation of Corrective and Preventive Actions (CAPA).
- Review adverse event cases, product quality complaints, and medical information for compliance.
- Support client audits, regulatory inspections, and sponsor interactions.
- Track training schedules, create training materials, and guide new hires.
- Respond to medical information/product quality queries via telephone, email, or fax.
- Maintain documentation for compliance with EU, FDA, and global regulatory requirements.
Qualifications
Minimum Required:
- Bachelor’s, Master’s, or PhD in Medicine, Pharmaceutical Science, Life Sciences, Biological Sciences, Nursing, or related fields.
- 2+ years in pharmaceutical, biotech, or CRO industry, mainly in pharmacovigilance and safety writing.
- Knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and ICH Guidelines.
- Understanding of global adverse event reporting and regulatory requirements.
- Proficiency in Microsoft Office suite.
Preferred:
- Experience in generating quality metrics with trend analysis.
- Authoring and coordinating CAPA reports.
- Knowledge of medical device reporting is a plus.
Benefits
- Opportunity to work in a global pharmaceutical/CRO environment.
- Exposure to regulatory inspections, audits, and compliance processes.
- Learning and development support in process improvement and quality excellence.
- Office or remote work flexibility with minimal travel (10%).
How to Apply
Advertisement
