Pharmacovigilance work scales up suddenly: a product launch, a new indication, a backlog of cases or a regulatory request can double the workload in a quarter. Knowing which roles you need, and which can flex, keeps safety compliant without overbuilding headcount.
Core roles
- Case processing specialists intake, triage, code (MedDRA) and narrate individual case safety reports, and manage follow-up to meet expedited reporting timelines
- Safety physicians and medical reviewers assess seriousness, expectedness and causality
- Aggregate reporting writers prepare periodic reports such as PSURs/PBRERs, DSURs and PADERs
- Signal detection and risk management scientists analyze trends, evaluate signals and maintain risk management plans
- Safety database specialists configure and maintain systems such as Oracle Argus or ArisGlobal, including validation and reporting rules
- PV quality and compliance to run audits, inspection readiness and the pharmacovigilance system master file where EU obligations apply
What to staff on contract
Case processing backlogs, aggregate report peaks, database migrations and inspection preparation are natural contract work: defined, time-bound and well understood by experienced consultants. Signal management and medical review leadership are usually better as permanent roles because they carry long-term product knowledge.
What to screen for
- Which safety database and version they've worked in daily
- Volume and type of cases (clinical trial vs. post-marketing, device vs. drug)
- Which periodic reports they've authored, not just contributed to
- Experience with inspections or audits of the safety function