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
