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SpecialismPharmacovigilance
Drug safety is a high-volume, deadline-bound function. The best hires combine case-processing accuracy with enough medical judgement to move into review, aggregate reporting or signal work.
Roles we recruit
- ICSR case processor and reviewer
- Drug safety physician / medical reviewer
- Safety scientist
- Aggregate report writer (PSUR/PBRER, DSUR)
- Signal detection specialist
- Risk management and QPPV-office roles
Skills and systems we screen for
- ICSR processing and MedDRA coding
- Aggregate reports (PBRER, DSUR)
- Signal detection and evaluation
- Argus Safety, ArisG, Veeva Vault Safety
- Literature surveillance
- Reconciliation and SDEA oversight
What we ask in the screening call
- Case volume and complexity handled
- Safety database and coding tools used
- Product types (small molecule, biologic, device)
- Regulatory inspection exposure
Regulatory frameworks
Reference points we use when briefing and screening.
- EMA GVP modules
- FDA (21 CFR 312, 314)
- PvPI / CDSCO (India)
- MHRA