Functional Quality Associate II
Location: Pune
Employment Type: Full-Time
Job Requisition ID: 256051
Job Summary
The Functional Quality Associate II is responsible for supporting quality assurance and compliance activities within Pharmacovigilance (PV) and Drug Safety Operations. The role focuses on conducting quality reviews of safety reports, monitoring compliance with regulatory requirements, supporting audits and inspections, managing quality metrics, and assisting with CAPA (Corrective and Preventive Action) activities.
The position plays a critical role in ensuring the accuracy, consistency, and regulatory compliance of safety documentation, adverse event reporting, medical information handling, and quality management processes.
Key Responsibilities
Quality Review & Compliance
Perform quality reviews of:
Individual Case Safety Reports (ICSRs)
Adverse Event Reports
Safety Narratives
Regulatory Safety Documents
Review safety reports from both:
Clinical Trial Studies
Post-Marketing Surveillance Programs
Assess quality from:
Medical Perspective
Scientific Perspective
Documentation Perspective
Ensure compliance with:
ICH Guidelines
GCP (Good Clinical Practice)
GVP (Good Pharmacovigilance Practices)
Client-specific requirements
Quality Metrics & Trend Analysis
Assist in generating quality metrics and performance reports.
Analyze quality review findings and identify trends.
Support quality improvement initiatives based on trend analysis.
Contribute to discussions related to recurring quality issues and process enhancements.
CAPA Management
Assist in preparing:
Corrective Action Plans (CAPA)
Preventive Action Plans
Support implementation and tracking of CAPA activities.
Coordinate with Project Managers to ensure CAPA effectiveness.
Maintain documentation demonstrating CAPA completion and compliance.
Pharmacovigilance & Drug Safety Support
Review and assess:
Expedited Adverse Event Reports
Product Quality Complaints (PQCs)
Medical Information Cases
Ensure submissions are completed within regulatory and client timelines.
Support drug safety data management activities including:
Call Intake Review
Case Documentation Review
Case Follow-Up Activities
Guide Safety Associates regarding call handling and safety case management when required.
Regulatory Documentation Review
Review and quality check various regulatory safety documents, including:
Annual Reports (IND and Non-IND)
PSURs (Periodic Safety Update Reports)
PADERs (Periodic Adverse Drug Experience Reports)
Bridging Reports
Investigator Brochures
Clinical Study Reports (CSRs)
Protocol Sections
Core Data Sheets (CDS)
US Prescribing Information (USPI)
Summary of Product Characteristics (SPCs)
Medication Guides (MedGuides)
Medical Information & Product Quality Complaints
Review and respond to:
Medical Information Queries
Product Quality Complaints
General Product Inquiries
Handle communications received through:
Telephone Calls
Emails
Fax
Other Reporting Channels
Ensure information is accurately documented and reported according to sponsor procedures.
Audit & Inspection Support
Support internal and external audits.
Assist in preparing project documentation for regulatory inspections.
Coordinate with project teams during sponsor inspections and regulatory audits.
Ensure audit readiness through proper documentation and compliance practices.
Training & Process Improvement
Assist in developing:
Training Materials
Training Plans
Training Schedules
Support onboarding and training of new team members.
Participate in quality forums and process improvement initiatives.
Suggest opportunities for operational excellence and quality enhancement.
Additional Responsibilities
Perform ongoing quality control activities.
Reconcile data from multiple systems and sources.
Track operational metrics and compliance indicators.
Support assigned quality and compliance projects as required.
Required Qualifications
Educational Requirements
Bachelor's, Master's, PharmD, MD, BAMS, BHMS, BDS, Nursing, Life Sciences, Biological Sciences, Pharmaceutical Sciences, Medical Sciences, or related healthcare/scientific discipline.
PhD candidates with relevant experience may also be considered.
Required Experience
Experience Level
2+ years of experience in:
Pharmacovigilance
Drug Safety
Safety Writing
Quality Review
CRO or Pharmaceutical Industry
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