Functional Quality Associate II
Location: Pune, India
Job Type: Full-Time
Department: Pharmacovigilance / Quality Assurance
Experience Required: 2+ Years
Industry: Pharmaceutical / Biotechnology / CRO
Job Summary
The Functional Quality Associate II is responsible for supporting quality assurance activities within Pharmacovigilance and Drug Safety operations. The role involves conducting quality reviews of safety reports, monitoring compliance with regulatory requirements, supporting CAPA activities, analyzing quality trends, and ensuring high-quality delivery of safety and regulatory documentation.
The incumbent will collaborate with cross-functional teams to maintain quality standards, support audits and inspections, contribute to process improvements, and ensure compliance with global pharmacovigilance regulations and client requirements.
Key Responsibilities
Quality Review & Compliance
Perform quality review of adverse event cases, safety reports, and pharmacovigilance documentation.
Conduct ongoing quality review of safety reports and regulatory submission documents.
Review product quality complaints, medical information inquiries, and general safety-related communications.
Ensure compliance with company SOPs, client requirements, GCP, GVP, and applicable global regulations.
Participate in process compliance reviews and quality assessments.
Quality Metrics & Trend Analysis
Generate and analyze quality metrics to identify trends and areas for improvement.
Support preparation of quality reports and periodic quality reviews.
Assist in root cause analysis of quality findings and deviations.
Contribute to continuous process improvement initiatives.
CAPA Management
Assist in preparation, tracking, and implementation of Corrective and Preventive Actions (CAPA).
Coordinate with project teams to ensure timely CAPA execution.
Maintain documentation and evidence of CAPA effectiveness.
Pharmacovigilance Operations
Review expedited adverse event reports and ensure compliance with reporting timelines.
Support management of adverse events collected from clinical trials and post-marketing sources.
Review case processing activities and ensure accuracy of safety data.
Provide guidance to safety associates on case handling and quality expectations.
Participate in reconciliation and quality control activities across safety databases and systems.
Regulatory Documentation Review
Review and provide quality oversight for:
Annual Reports (IND and other regulatory submissions)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Clinical Study Reports (CSRs)
Core Data Sheets (CDS)
Investigator Brochures
Product Labeling Documents
USPI, SPCs, MedGuides
Bridging Reports
Protocol Safety Sections
Audit & Inspection Support
Assist in coordinating client audits and external quality assessments.
Support regulatory inspections and sponsor audits.
Participate in audit preparation and follow-up activities.
Contribute to development and maintenance of Quality Management Plans.
Training & Knowledge Management
Assist in designing and tracking training programs for new and existing employees.
Develop and maintain training materials related to quality and compliance processes.
Participate in quality discussion forums and knowledge-sharing initiatives.
Mentor and guide team members on quality-related requirements and best practices.
Medical Information & Call Review
Review medical information inquiries and product quality complaints received via telephone, email, or other communication channels.
Evaluate call documentation and follow-up records for completeness and compliance.
Support drug safety call intake review and quality monitoring activities.
Ensure appropriate documentation and response handling as per sponsor requirements.
Additional Responsibilities
Support tracking and reporting of operational metrics.
Conduct ongoing quality control reviews of assigned processes.
Perform data reconciliation activities from multiple sources.
Collaborate with cross-functional stakeholders to ensure timely issue resolution.
Perform additional quality and compliance activities as assigned.
Educational Qualifications
Required
Bachelor's, Master's, PharmD, MD, BDS, BHMS, BAMS, Nursing, Life Sciences, Biological Sciences, Pharmaceutical Sciences, Medical Sciences, or related healthcare discipline.
Preferred
Advanced degree in Life Sciences, Pharmacy, Medicine, or related field.
Experience Requirements
Required
Minimum 2 years of experience in:
Pharmacovigilance
Drug Safety
Safety Writing
Quality Review / Peer Review
CRO, Pharmaceutical, or Biotechnology industry
Preferred
Experience in quality metrics generation and trend analysis.
Experience in CAPA authoring and management.
Experience reviewing safety cases from medical, scientific, and documentation perspectives.
Exposure to global pharmacovigilance processes and quality systems.
Required Knowledge & Skills
Regulatory Knowledge
ICH Guidelines
Good Clinical Practice (GCP)
Good Pharmacovigilance Practices (GVP)
EU Pharmacovigilance Regulations
FDA Pharmacovigilance Requirements
Global adverse event reporting regulations
Clinical safety and post-marketing surveillance requirements
Technical Skills
Strong understanding of case processing and case assessment.
Knowledge of medical and drug terminology.
Knowledge of medical device vigilance reporting (preferred).
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
Experience with safety databases and pharmacovigilance systems.
Soft Skills
Strong analytical and problem-solving abilities.
Excellent attention to detail.
Effective written and verbal communication skills.
Ability to work in cross-functional and global teams.
Strong organizational and time-management skills.
Ability to identify quality risks and implement corrective actions.
Competencies
Quality & Compliance Focus
Pharmacovigilance Expertise
Regulatory Awareness
Critical Thinking
Data Analysis & Trend Identification
Process Improvement Mindset
Stakeholder Management
Team Collaboration
Audit Readiness
Work Environment
Office-based / Hybrid (as applicable)
Fast-paced global pharmacovigilance environment
Collaboration with internal teams, clients, sponsors, and regulatory stakeholders
Why Join Us?
Opportunity to work on global pharmacovigilance and drug safety programs.
Exposure to international regulatory requirements and quality systems.
Career growth in Quality Assurance and Pharmacovigilance.
Collaborative and learning-focused work environment.
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