Functional Quality Associate II – Pharmacovigilance
Job ID: 256051
Location: Mumbai, India
Employment Type: Full-time
Function: Clinical Quality / Pharmacovigilance
Industry: Pharmaceuticals / CRO / Life Sciences
Work Mode: Office-based or Remote
Role Overview
We are seeking a Functional Quality Associate II to support global pharmacovigilance and clinical safety operations. This role is responsible for performing quality reviews of safety data, regulatory documents, and pharmacovigilance processes to ensure compliance with global regulatory standards and client requirements.
The position plays a critical role in maintaining high-quality safety reporting across clinical and post-marketing environments while supporting audits, inspections, and continuous quality improvement initiatives.
Key Responsibilities
Quality Review & Compliance
Perform quality review of individual case safety reports (ICSRs) and safety-related documentation
Conduct ongoing review of safety reports and regulatory documents, including PSURs, PADERs, IND annual reports, clinical study reports, investigator brochures, and core data sheets
Review expedited adverse events, product quality complaints, and medical information cases to ensure accuracy, completeness, and regulatory compliance
Support global regulatory submissions and labeling documentation as per sponsor and regulatory requirements
Metrics, CAPA & Process Improvement
Compile quality metrics, analyze trends, and support periodic client quality reviews
Assist in the development, implementation, and documentation of Corrective and Preventive Actions (CAPAs)
Monitor CAPA effectiveness in coordination with project and quality management teams
Identify quality risks and propose process improvement strategies
Audit & Inspection Support
Support internal, client, and regulatory audits and inspections
Assist in the development and maintenance of Quality Management Plans for assigned projects
Coordinate with project teams to support sponsors during regulatory inspections
Safety Operations Support
Execute drug safety data management activities including call intake review, case follow-up, and documentation review
Review and respond to medical information queries and product quality complaints via phone, email, or other communication channels
Guide and support safety associates in managing voice calls and safety workflows
Perform reconciliation and ongoing QC of defined pharmacovigilance process steps
Training & Knowledge Sharing
Support development and tracking of training plans and materials for new hires and existing team members
Participate in quality forums to discuss errors, best practices, and continuous improvement opportunities
Required Qualifications
Bachelor’s, Master’s, or PhD degree in Medicine, Alternative Medicine, Pharmacy, Pharmaceutical Sciences, Medical Sciences, Nursing, Life Sciences, or a related discipline
Required Experience
Minimum 2+ years of experience in the pharmaceutical, biotechnology, or CRO industry
Hands-on experience in Pharmacovigilance, Safety Writing, or Case Processing, with exposure to peer review or quality review activities
Strong understanding of case processing, safety assessment, and global safety reporting requirements
Preferred Qualifications
Experience generating quality metrics, trend analysis, and CAPA documentation
Experience performing quality review of safety cases from medical, scientific, and documentation perspectives
Familiarity with medical device safety reporting
Experience supporting regulatory audits and inspections
Key Skills & Competencies
Strong knowledge of medical and drug terminology
Working knowledge of ICH guidelines, GCP, GVP, EU and FDA pharmacovigilance regulations
Ability to analyze data, identify quality trends, and recommend corrective actions
Strong communication skills with the ability to collaborate across functions
High attention to detail and problem-solving capabilities
Proficiency in Microsoft Office applications
Work Environment
This role operates in an office-based or remote work environment, depending on business requirements.
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