PV-Case Processing / Aggregate reports - Associate | Lead

Location: Pune, Bengaluru, Hyderabad, Mumbai  •  Level: Senior Level  •  Openings: 50  •  Type: Full-time
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Job description

1. 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
2. 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
3. Education and Certification
Qualification: Any Life Science Graduate
Specific Remarks: Distance education not accepted.
Certification: Not Applicable
4. 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
5. Key Skills
PSUR / PBRER, PV, ICSR, Case Narrative Writing
6. Other Specific Remarks
Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory 

Job ID: 2034