Functional Quality Associate II
Company
Fortrea – A global clinical research organization providing drug development and pharmacovigilance services to support safe and effective healthcare solutions.
Job Details
Job Title: Functional Quality Associate II
Job Requisition ID: 256051
Employment Type: Full-time
Location: Pune, India
Work Environment: Office
Job Overview
The Functional Quality Associate II is responsible for ensuring high-quality service delivery for both internal and external clients in a safe, compliant, and cost-effective manner.
This role focuses on quality review of safety and pharmacovigilance data, regulatory documentation, and support of compliance processes aligned with global safety standards and legal requirements.
Key Responsibilities
1. Quality Review & Safety Reporting
Perform quality review of:
Safety reports
Adverse event reports
Product quality complaints
Review samples of safety data for regulatory submissions including:
IND Annual Reports
PSURs
PADERs
Clinical Study Reports
Core Data Sheets
USPI and SPC documents
Investigator brochures
2. Pharmacovigilance Operations
Manage and review:
Expedited adverse event reports
Product quality complaints
Medical information queries
Ensure submissions are completed within required regulatory timelines.
Support end-to-end adverse event processing including:
Case intake
Documentation review
Follow-up activities
3. Quality Systems & CAPA
Assist in development and implementation of:
Corrective and Preventive Actions (CAPA)
Quality Management Plans
Ensure CAPA actions are completed and documented.
Support identification of quality trends and improvement areas.
4. Compliance & Audit Support
Support internal and external audits.
Assist regulatory inspections and sponsor audits.
Ensure adherence to:
ICH guidelines
GCP
GVP requirements
Global pharmacovigilance regulations
5. Data Analysis & Reporting
Assist in generating quality metrics and trend analysis.
Contribute to process improvement recommendations.
Maintain tracking systems and documentation accuracy.
6. Training & Mentorship
Assist in training coordination for new and existing staff.
Support knowledge sharing on quality errors and process improvements.
Guide safety associates in call handling and documentation (as required).
7. Medical Information & Query Handling
Review and respond to:
Medical information queries
Product complaints
General inquiries (via phone, email, fax)
Ensure accurate documentation and timely response.
Required Qualifications
Education
Bachelor’s / Master’s / PhD in:
Medicine
Pharmaceutical Sciences
Medical Sciences
Nursing
Life Sciences
Biological Sciences
Or related fields
Experience
Minimum 2+ years of experience in:
Pharmaceutical / biotechnology / CRO industry
Pharmacovigilance or safety writing
Quality review or peer review activities
Technical Knowledge
Strong understanding of:
Medical and drug terminology
ICH Guidelines
GCP and GVP regulations
Global pharmacovigilance requirements (EU, FDA, etc.)
Knowledge of:
Case processing and safety assessment
Medical device reporting (preferred)
Proficiency in Microsoft Office tools
Preferred Skills
Experience in:
Quality metrics and trend analysis
CAPA development and tracking
Safety report quality assessment
Strong analytical and problem-solving skills.
Ability to identify issues proactively and implement corrective actions.
Work Environment
Office-based role
Inclusion & Accessibility
Fortrea is committed to equal opportunity employment and fostering an inclusive workplace.
Reasonable accommodations are available during the recruitment process upon request.
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