Team Lead - Case Processing

Soterius Life Sciences

Posted: 3 weeks ago
Openings: 10
Applicants: 0

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

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