PV-Case Processing / Aggregate reports - Associate | Lead

Golden Opportunities; Hyderabad; On-site; INR 400,000 - 700,000; Full time

Job summary

Golden Opportunities in Hyderabad, India seeks a Pharmacovigilance Case Processing professional to manage case intake, labeling, and narrative writing within a strict regulatory framework.

You will supervise a team of QR associates, monitor quality metrics and turnaround times, handle escalations, and contribute to CAPA and audit readiness to ensure compliant deliverables. You will also participate in onboarding, training, and ongoing process improvements to sustain high-quality outputs.

Qualifications

• Experience in pharmacovigilance case processing and labeling.
• Strong narrative writing and documentation skills.
• Familiarity with regulatory timelines and audit readiness.

Responsibilities

• Oversee day-to-day case processing operations and team workload.
• Ensure quality checks, timely TAT/SLA adherence, and defect reduction.
• Conduct quality audits and provide coaching to associates.
• Handle escalations for complex cases and support regulatory decisions.
• Drive CAPA actions to prevent recurring defects.

Skills

Pharmacovigilance Case Processing

Labeling Expertise

Narrative Writing

Quality Review

Regulatory Knowledge

Safety Databases

Job description

Job Description

• Book-in, full data entry, narrative writing/I-Narrative, medical coding, product coding, self-check of an online QC tool, un-blinding (if required), case routing, case lock/closure where applicable, and labeling including USPI labeling.
• Quality check of fatal & serious cases, keep daily track of quality metrics of case-processing defects, communicate quality metrics to case processing associates, and discuss steps taken to correct errors to ensure deliverable quality.
• Supervise day-to-day operations of a team of Case Processing Associates/QR Associates; allocate case inventory and manage workflow distribution.
• Monitor individual and team productivity, quality, and TAT/SLA metrics; conduct periodic case audits and provide coaching/feedback.
• Handle escalations for complex or ambiguous cases; support un-blinding and case lock/closure decisions where required.
• Support onboarding and training of new associates; conduct calibration sessions to align on coding/narrative standards.
• Manage multiple sub-teams (through Team Leaders) responsible for case processing, medical coding, and quality review across the project.
• Own end-to-end delivery metrics (quality, TAT, volume) for the assigned scope; drive corrective and preventive actions (CAPA) for recurring defects.
• Ensure adherence to SOPs, regulatory timelines, and audit/inspection readiness.

Skill Set

• Pharmacovigilance Case Processing
• Labeling Expertise
• Narrative Writing
• Quality Review
• Regulatory Knowledge
• Safety Databases