Team Lead - Case Processing

Soterius, Inc.; Mumbai; On-site; INR 2,500,000 - 3,200,000; Full time

Job summary

Soterius, Inc. in Mumbai seeks a Team Leader to oversee a high-volume pharmacovigilance case processing program. You will lead an operational team across intake, triage, submission, processing and QC, ensuring timely, compliant delivery.

The role involves managing workload, coaching staff, and maintaining inspection readiness within a fast-paced OTC/pharmacovigilance environment.

Qualifications

• Degree in Pharmacy, Pharm D, BHMS, BDS or equivalent.

Responsibilities

• Lead an operational case processing team, managing daily workload allocation, productivity, and quality across the case lifecycle.

Skills

Case processing leadership

E2B submissions

EudraVigilance

Inline QC

Safety database knowledge

MedDRA

Team/workload management

Education

Pharmacy or pharma-related degree

Pharm D

BHMS

BDS

Job description

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
• 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