Functional Quality Associate II – Clinical Safety & Pharmacovigilance
Location: Pune, Maharashtra, India
Employment Type: Full-Time
Experience Required: 2+ years in Pharmacovigilance, Clinical Safety, or Quality Review
About the Role
We are seeking a detail-oriented Functional Quality Associate II to join our Clinical Operations and Pharmacovigilance team in Pune. The ideal candidate will support the quality review of safety reports, regulatory documentation, and pharmacovigilance processes, ensuring compliance with global regulatory requirements and client-specific standards. This role is critical for maintaining the accuracy, timeliness, and compliance of safety and quality deliverables in clinical trials and post-marketing settings.
Key Responsibilities
Conduct quality review of adverse event safety reports and regulatory submissions, including PSURs, PADERs, Clinical Study Reports (CSR), Core Data Sheets, USPI, Investigator Brochures, and other labeling/regulatory documents.
Support compilation of quality metrics and trend analysis to identify opportunities for process improvement.
Assist in preparation and tracking of Corrective and Preventive Actions (CAPA), ensuring implementation and documentation.
Manage review and follow-up of expedited adverse events, product quality complaints, and medical information queries in line with client timelines and regulatory standards.
Provide guidance and oversight to junior safety associates in case processing, documentation review, and data reconciliation.
Assist in designing and tracking training schedules and materials for new hires and ongoing staff development.
Support regulatory inspections and client audits, coordinating with project teams and Quality Leads to ensure compliance.
Contribute to process improvement initiatives, quality forums, and discussions on error mitigation and operational excellence.
Execute pharmacovigilance data management processes including call intake review, documentation, case follow-up, and reporting in alignment with global standards.
Required Qualifications & Skills
Bachelor’s, Master’s, or PhD in Medicine, Pharmaceutical Sciences, Nursing, Life Sciences, Biological Sciences, or a related field.
Minimum 2 years of experience in the pharmaceutical, biotechnology, or CRO industry, with a focus on Pharmacovigilance, Clinical Safety, or Quality Review.
Knowledge of medical and drug terminology, ICH Guidelines, Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP).
Understanding of worldwide regulatory requirements for adverse event reporting for marketed and investigational products, including FDA and EU guidelines.
Experience with peer review, quality assessment of safety cases, and documentation standards.
Strong analytical, organizational, and problem-solving skills, with the ability to work independently and collaboratively.
Technical proficiency with Microsoft Office applications.
Preferred Qualifications
Experience generating quality metrics with trend analysis and reporting CAPA outcomes.
Prior exposure to assessing medical and scientific accuracy of safety reports.
Knowledge of Medical Device reporting and post-marketing surveillance processes.
Work Environment
Office-based in Pune, with flexibility for remote work as per organizational policy.
Why Join Us
Opportunity to contribute to high-impact pharmacovigilance and clinical safety projects.
Work in a collaborative, inclusive, and innovative environment.
Gain exposure to global regulatory standards, client engagement, and continuous learning opportunities.
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