PV-Case Processing / Aggregate reports - Associate | Lead
Location: Pune, Bengaluru, Hyderabad, Mumbai
• Experience: Senior Level
• Openings: 10
Job description
Job Description:
Book-in, full data entry, narrative writing/I-Narrative, medical coding,
product coding, self-check of 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, to keep daily track of
quality metrics of the case-processing defects, communication of quality
metrics to case processing associates and discussion about steps taken to
correct the errors, ensure the quality of the deliverable is as expected
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.
Must have
Skill Set
Pharmacovigilance Case Processing
Labeling Expertise
Narrative Writing
Quality Review
Regulatory Knowledge
Safety Databases