- 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 & responsible 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

📌 PV-Case Processing (Hyderabad)
🏢 Golden Opportunities
📍 Hyderabad