The problem
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.
Tell us the problem. A specialist replies, not a form robot.
What we do
ICSR intake, triage, data entry, narrative writing and submission at volume.
Regulatory timelines tracked from the day of awareness, not the day of entry.
PSUR, PBRER, DSUR and periodic safety updates.
Detection, evaluation and documented decision-making.
RMPs, REMS support and post-authorisation commitments.
Screening and assessment on a defined, auditable schedule.
For consultants
PV is a discipline where trained people are consistently short and demand is steady rather than cyclical.
Proof
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
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.
The major commercial systems used across the industry. We screen for the specific platform you run rather than assuming transferability.
That is the point of the model. Contract structures let capacity come off cleanly when volume settles.
Yes, PV physicians and medical reviewers, though these are scarcer profiles and take longer to place.
Case processing is often delivered offshore with onshore oversight and medical review. We will be explicit about which parts sit where.
Related
Hiring for it, or looking for the work. Either conversation is welcome.