Team Lead - Case Processing

Soterius Life Sciences; Mumbai; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Soterius Life Sciences in Mumbai seeks a Team Leader for pharmacovigilance case processing in a high-volume OTC/consumer health program. You will lead an operational team across intake, triage, submission, processing, and QC, ensuring timely, compliant completion of cases.

Responsibilities include data entry, MedDRA coding, narrative writing, E2B submissions, and ongoing QC, with focus on inspection readiness and staff development.

Qualifications

• 6+ years of related experience in pharmacovigilance, drug safety, or allied domains.
• Proven leadership of an operational case processing team in a high-volume setting.

Responsibilities

• Lead an operational case processing team, managing daily workload allocation, productivity, and quality across the case lifecycle.
• Oversee case intake, book-in, triage, and validity assessment in line with SOPs.
• Manage ICSR data entry, MedDRA coding, and narrative writing for cases.
• Oversee E2B submissions, gateway operations, EudraVigilance downloads, and mailbox management.
• Perform and oversee inline quality control, monitoring error trends and QC metrics.
• Ensure end-to-end case processing meets compliance timelines and quality standards.
• Manage team performance, escalations, training, and development.

Skills

Case processing leadership

ICSR data entry

MedDRA knowledge

Team workload management

Quality monitoring

Education

Degree in Pharmacy / PharmD / BHMS / BDS

Tools

Argus Veeva

LSMV

MedDRA

Job description

Job Overview

Team leader accountable for case processing operations within a large-volume OTC/consumer healthcare pharmacovigilance program. Reports to the Case Management Lead and leads an operational team across the end-to-end case lifecycle, including intake, triage, submission, processing, and quality. Team Leads are deployed flexibly across these areas based on operational need.

Qualification and Experience

• Degree in Pharmacy, Pharm D, BHMS, BDS or equivalent.
• 6+ years of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains

Key Responsibilities

• Lead an operational case processing team, managing daily workload allocation, productivity, and quality across the case lifecycle.
• Oversee case intake, book-in, triage, and validity assessment in line with program SOPs.
• Manage ICSR data entry, MedDRA coding, and narrative writing for cases.
• Oversee E2B submissions, gateway operations, EudraVigilance downloads, and mailbox management where assigned.
• Perform and oversee inline quality control, monitoring error trends and QC metrics.
• Ensure end-to-end case processing meets compliance timelines and quality standards.
• Manage team performance, escalations, training, and development.
• Maintain inspection readiness and support audits and inspections across the case processing function.

Key Skills

• Case processing team leadership across intake, triage, submission, processing, and QC
• ICSR data entry, coding, narrative writing
• E2B submission and gateway operations
• EudraVigilance and mailbox management
• Inline QC and error trend analysis
• Safety database knowledge - LSMV, Argus Veeva or equivalent
• MedDRA
• Team, workload, and compliance management
• Consumer health