Pharmacovigilance Services Analyst

Key Responsibilities
• Oversee adherence to Quality Management Framework procedures to ensure delivery of high-quality pharmacovigilance cases
• Review and improve project Quality Management Systems and suggest process enhancements
• Collaborate with Team Leads, Trainers and Medical Reviewers to implement new or enhanced quality processes
• Coordinate with Quality Reviewers to maintain compliance with quality standards
• Review late logs, perform Root Cause Analysis (RCA) and define Corrective and Preventive Actions (CAPA)
• Ensure timely documentation and closure of late logs as per client SOPs
• Conduct training, refresher sessions and awareness programs on case processing conventions
• Work with Operational Excellence and Capability Development teams to enhance engagement quality
• Support audits, inspections, SOP development and maintenance
• Review safety case data for completeness and accuracy
• Track, submit and distribute quality and compliance reports
• Maintain client mailboxes, SharePoint, databases and safety tools
• Drive zero quality deviations leading to regulatory submission delays
• Support transitions, documentation archiving, and cross-functional coordination

Skills & Competencies
• Working knowledge of ICH, GCP, FDA, MHRA and global PV regulations
• Strong attention to detail and data accuracy
• Good understanding of medical terminology
• Strong verbal and written communication skills
• Proficiency in MS Excel, Word and PowerPoint
• Strong interpersonal and stakeholder management skills

About Accenture
Accenture is a global professional services company delivering Strategy & Consulting, Technology and Operations services across more than 120 countries. With industry-leading capabilities in digital, cloud and security, Accenture supports global life sciences clients through advanced technology and intelligent operations centers.