PV-Case Processing / Aggregate reports - Associate | Lead - GO/JC/4911/2026

• Job Details

Job Title: PV-Case Processing / Aggregate reporting – Associate / Sr. Associate / Lead/ Manager

Job Location: Mumbai, Pune, Hyderabad, Bangalore

Work Model: Mandatory Work from Office

• Candidate Expectations

Total and Relevant Experience - 1.5 Years to 10 Years

Candidate Location - Anywhere

Skills – Pharmacovigilance, ICSR, Aggregate reporting

Candidate Industry (BPO)

Diversity – No

• Education and Certification

Qualification: Any Life Science Graduate

Specific Remarks: Distance education not accepted.

Certification: Not Applicable

• Detailed 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.
• Report team performance metrics to Team Manager; identify and drive process improvement opportunities.
• 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.
• Conduct resource planning, capacity forecasting, and shift/roster management to meet case volume fluctuations.
• Participate in client calls to present performance dashboards, discuss quality trends, and align on process changes.
• Conduct performance appraisals, goal-setting, and career development planning for Team Leaders and associates.
• Ensure adherence to SOPs, regulatory timelines, and audit/inspection readiness.
• Develop, maintain, and update training plans, materials, and training records in compliance with quality and regulatory requirements.
• Track and drive training compliance, ensuring timely completion of mandatory trainings and SOP updates.
• Conduct training needs analysis, identify knowledge gaps, and implement improvement initiatives to enhance team performance
• Support end-to-end preparation of PSURs, DSURs, PADERs, and Addendum reports, including retrieval of source documents, use of current templates, and report drafting in accordance with client requirements.
• Coordinate with cross-functional stakeholders and business partners to obtain, review, consolidate, and address inputs, comments, and feedback throughout the report development process.
• Perform data extraction and analysis activities, including generation of safety database line listings and incorporation of relevant safety information into reports.
• Ensure high-quality deliverables through peer review, QC coordination, comment resolution, finalization, approvals, and responses to stakeholder feedback.
• Manage report lifecycle activities, including tracking KPIs, document management system updates, publishing coordination, and archival of final reports and supporting documentation.
• Training and mentoring of other aggregate reports writers
• Key Skills

PSUR / PBRER, PV, ICSR, Case Narrative Writing

• Other Specific Remarks

Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory