The problem
Pharmacovigilance is the one function where falling behind is immediately reportable.
Most functions can absorb a bad month. Safety cannot. Expedited reporting timelines are fixed, they run from the day of awareness, and a backlog is not an internal problem, it is a compliance finding waiting to be documented.
Volume is also unpredictable in exactly the way headcount planning is not. A safety signal, a label change or a launch can multiply case volume in a quarter, and hiring cycles do not move at that speed.
Which makes this the clearest case for flexible capacity in the whole sector: trained people who can be added when volume moves and released when it settles.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we cover.
Case processing
ICSR intake, triage, data entry, narrative writing and submission at volume.
Expedited reporting
Regulatory timelines tracked from the day of awareness, not the day of entry.
Aggregate reports
PSUR, PBRER, DSUR and periodic safety updates.
Signal detection
Detection, evaluation and documented decision-making.
Risk management plans
RMPs, REMS support and post-authorisation commitments.
Literature monitoring
Screening and assessment on a defined, auditable schedule.
For consultants
Roles we place in pharmacovigilance.
PV is a discipline where trained people are consistently short and demand is steady rather than cyclical.
- Drug Safety Associates and Specialists
- Case Processing Associates
- Aggregate Report Writers
- Signal Detection Scientists
- PV Physicians and Medical Reviewers
- QPPV support and PV Systems Specialists
Proof
Fixed
Expedited reporting clocks. They do not care about your resource plan.
Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.
Questions
Questions we get asked.
Can you handle a backlog?
Yes, and it is a common reason clients call. It starts with an honest assessment of the backlog size and reportability exposure before anyone touches a case.
Which safety databases do you work with?
The major commercial systems used across the industry. We screen for the specific platform you run rather than assuming transferability.
Can you scale up and back down?
That is the point of the model. Contract structures let capacity come off cleanly when volume settles.
Do you provide medical review?
Yes, PV physicians and medical reviewers, though these are scarcer profiles and take longer to place.
Onsite or remote?
Case processing is usually delivered remotely by US-based teams, with oversight and medical review alongside. We will be explicit about which parts sit where.
Related
Where to go next.
Talk to someone who has done this.
Hiring for it, or looking for the work. Either conversation is welcome.