Pharmacovigilance consultants and PV services
Drug safety professionals and managed case-processing teams for sponsors who cannot afford a backlog.
The problem we solve
A PV backlog is a compliance finding waiting to happen.
Case volumes spike after a launch, a label change or a media story, and 15-day clocks do not pause. Aggregate reports fall due whether or not the person who wrote the last one is still employed. Inspectors look first at timeliness.
Vakula supplies experienced drug safety associates, physicians and PV scientists to absorb volume, and runs case processing as an ongoing managed service with agreed turnaround SLAs.
Tell us what you need
A consultant replies, not an auto-responder. Typical response inside one business day.
By submitting you agree to our Privacy Policy. We do not share your details with third parties.
What we do
Pharmacovigilance capabilities
ICSR case processing
Intake, triage, data entry, MedDRA coding, narrative writing, medical review and regulatory submission within compliance timelines.
Aggregate reporting
PSUR/PBRER, DSUR, PADER and addendum reports planned, authored and QC-checked.
Signal management
Signal detection, validation and assessment with documented decisions.
Safety database support
Argus, ArisGlobal and Veeva Vault Safety configuration, migration and user support.
PV quality and audit readiness
SOPs, PSMF maintenance, CAPA and mock inspections.
Literature and risk management
Literature screening, RMP and REMS support.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
Which safety databases do your people know?
Oracle Argus, ArisGlobal LifeSphere and Veeva Vault Safety most commonly, with several consultants experienced in database migrations between them.
Can you provide medical review?
Yes, through physicians experienced in PV medical review, on a part-time or case-volume basis.
How are SLAs set for managed case processing?
By case type and seriousness, agreed in the statement of work, with monthly compliance reporting.
Do you offer QPPV or US agent services?
We can supply experienced safety professionals to support a QPPV office; formal QPPV appointment depends on jurisdiction and is discussed case by case.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.