Job Title: Functional Quality Associate II – Pharmacovigilance
Location: Mumbai, India
Employment Type: Full-Time
Work Mode: Office-based / Remote (as per project requirement)
Job Requisition ID: 256051
Job Overview
We are seeking a detail-oriented Functional Quality Associate II to support global pharmacovigilance and safety quality operations. The role is responsible for conducting quality reviews of safety deliverables, supporting corrective and preventive action (CAPA) initiatives, and ensuring compliance with global regulatory standards.
The position plays a critical role in maintaining quality excellence across clinical trial and post-marketing safety activities, supporting internal teams, sponsors, and regulatory inspections while ensuring accurate, timely, and compliant safety documentation.
Key Responsibilities
Quality Review & Compliance
Perform quality reviews of safety reports and case documentation for global regulatory submissions.
Review safety deliverables including:
Annual Reports (IND and non-IND)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Clinical Study Reports (CSRs)
Core Data Sheets (CDS), USPI, SPCs, and Medication Guides
Investigator Brochures and protocol sections
Identify quality gaps, trends, and recurring errors; contribute to continuous quality improvement initiatives.
Assist in compiling quality metrics, dashboards, and trend analyses.
CAPA & Process Improvement
Support preparation, tracking, and implementation of Corrective and Preventive Actions (CAPAs).
Ensure CAPA outcomes are implemented and documented in coordination with project and quality leads.
Contribute to development and maintenance of Quality Management Plans for assigned projects.
Safety Operations & Case Review
Perform ongoing quality review of individual case safety reports (ICSRs) from clinical and post-marketing sources.
Review expedited adverse events, product quality complaints, and medical information cases for accuracy, completeness, and regulatory compliance.
Support drug safety data management processes including call intake review, documentation review, and case follow-up.
Guide safety associates in managing voice calls and safety intake activities when required.
Audit & Inspection Support
Assist in preparation and coordination of client audits and regulatory inspections.
Support sponsors during inspections by providing quality documentation and responses in collaboration with project teams.
Training & Cross-Functional Support
Assist in developing and tracking training plans and materials for new hires and existing team members.
Participate in internal quality forums and cross-functional discussions to address quality issues and process enhancements.
Perform additional support activities such as reconciliation, data tracking, and ongoing QC of defined safety processes.
Qualifications
Education
Bachelor’s, Master’s, or PhD degree in Medicine, Alternative Medicine, Pharmaceutical Sciences, Medical Sciences, Nursing, Life Sciences, Biological Sciences, or a related discipline
Experience Required
Minimum 2+ years of experience in the pharmaceutical, biotechnology, or CRO industry
Hands-on experience in Pharmacovigilance or Safety Writing, with exposure to peer review or quality review activities
Strong understanding of case processing, assessment, and safety documentation workflows
Core Skills & Knowledge
Knowledge of ICH-GCP, GVP, and global regulatory requirements (EU, FDA)
Understanding of adverse event reporting for clinical and post-marketing products
Familiarity with medical and drug terminology
Knowledge of medical device reporting is desirable
Ability to identify issues proactively and recommend corrective actions
Strong analytical, organizational, and documentation skills
Proficiency in Microsoft Office applications
Ability to communicate quality insights effectively across functions
Preferred Qualifications
Experience in quality metric generation and trend analysis
Exposure to authoring and coordinating CAPA reports
Experience assessing safety cases or reports from medical, scientific, and compliance perspectives
Work Environment
Office-based or remote work environment, depending on project needs
Why This Role Matters
This role provides an opportunity to work at the intersection of pharmacovigilance, quality assurance, and regulatory compliance, supporting global safety programs while contributing to continuous quality improvement and patient safety.
Apply now on thepharmadaily.com to advance your career in pharmacovigilance quality, safety compliance, and regulatory excellence.
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