MedDRA Specialist | Senior Process Compliance Review & Analysis
Company: Fortrea
Location: Pune, Maharashtra, India
Department: Pharmacovigilance / Quality & Compliance
Experience: 4+ Years
Job Type: Full-Time (Hybrid)
Fortrea is hiring a MedDRA Specialist / Senior Process Compliance Review & Analysis professional to support pharmacovigilance quality review, compliance monitoring, CAPA management, regulatory submissions review, and process improvement activities. The role focuses on quality oversight of safety cases, regulatory documents, audits, inspections, and pharmacovigilance compliance operations.
Quality Review & Compliance
Perform quality review of safety cases and pharmacovigilance deliverables
Identify quality trends and compile quality metrics
Support client quality reviews and compliance activities
Prepare and track CAPAs to closure
Pharmacovigilance Operations
Review adverse event cases and safety reports
Support global regulatory submissions and safety documentation
Review product quality complaints and medical information cases
Ensure compliance with global PV regulations and timelines
Regulatory & Safety Documentation
Review PSURs, PADERs, Annual Reports, Clinical Study Reports, Core Data Sheets, USPI, SPCs, and other regulatory documents
Ensure quality and regulatory compliance of safety deliverables
Support labeling and regulatory documentation review
Process Improvement & Training
Analyze quality trends and identify process improvement opportunities
Support training programs and quality awareness initiatives
Develop training materials and best-practice guidance
Participate in process reviews and quality forums
Audit & Inspection Support
Support client audits and regulatory inspections
Contribute to Quality Management Plans
Coordinate quality-related project activities
Maintain inspection readiness standards
Education
Bachelor's, Master's, PharmD, MBBS, BAMS, BHMS, Nursing, Life Sciences, Pharmaceutical Sciences, or related field
MedDRA Certification preferred
Experience
Minimum 4 years in Pharmacovigilance, Drug Safety, Safety Writing, or PV Quality
At least 1 year in Quality Review or Peer Review activities
Experience with case processing and safety assessments
Knowledge of EU GVP and FDA Pharmacovigilance requirements
Pharmacovigilance
MedDRA Coding & Review
Case Processing
Quality Review / Peer Review
CAPA Management
Regulatory Compliance
GVP Guidelines
FDA Regulations
Safety Writing
Signal & Trend Analysis
Audit & Inspection Readiness
Medical Information Review
Product Quality Complaints
Quality Assurance
Root Cause Analysis
Microsoft Office Suite
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