Real deployment
Cleared a 12-Month Pharmacovigilance Backlog in 16 Weeks
How a mid-size US pharma firm cleared a 4,200-case pharmacovigilance backlog and brought their FDA reporting back into compliance using an AB7 team of trained PV specialists working under a quality-controlled SOP.
Client
Mid-Size US Generics Pharma Firm (regulatory backlog risk)
Engagement
16-week intensive + ongoing monthly retainer
The challenge
What the client was up against.
A US generics pharma firm had accumulated a 4,200-case adverse-event reporting backlog over 12 months due to staff turnover in their pharmacovigilance (PV) team. FDA expedited reporting deadlines were being missed. An FDA inspection was scheduled in 5 months, and the firm faced potential 483 findings if the backlog wasn't cleared. Hiring local PV specialists in the US would take 4-6 months minimum and cost $130K+ per FTE. Outsourcing to traditional CROs was quoted at $1.2M for the engagement.
The solution
How AB7 deployed.
AB7 deployed a 6-person pharmacovigilance team (4 case processors + 1 medical reviewer + 1 quality lead) within 3 weeks. Every team member had pharma/clinical background, was trained on the client's safety database (Argus), and worked under a documented SOP with second-pair-of-eyes QC on every case. We organised the backlog into priority tiers (expedited 7-day cases first, then 15-day, then periodic reports) and ran a 4-shift weekly cadence to maximise throughput. A weekly QA audit caught data-integrity issues before submission.
Services engaged
What we plugged in.
- Pharmacovigilance Case Processing
- Adverse Event Reporting
- Argus Safety Database
- FDA Compliance Support
- Quality Assurance Audits
- Medical Review
Verified outcomes
The numbers, before and after.
Backlog cases cleared
Before
4,200 case backlog
After
0 — fully current
16-week clearance
Engagement cost
Before
$1.2M (CRO quote)
After
$340,000 (AB7)
72% cost savings
Time to staff up
Before
4-6 months (US hire)
After
3 weeks
8× faster ramp
FDA inspection result
Before
At risk of 483 findings
After
Zero findings
Compliance restored
Key takeaways
What this deployment proved.
Cleared 4,200-case PV backlog in 16 weeks under FDA pressure
Saved $860K vs the CRO alternative (72% cost reduction)
Stood up a trained PV team in 3 weeks vs. 4-6 months for US hires
Zero 483 findings at the FDA inspection that followed
Engagement transitioned to ongoing retainer for steady-state operations
“We were five months out from an FDA inspection with a 4,200-case PV backlog and no path to clear it on US-only hiring. AB7 stood up a trained team in three weeks and we walked into that inspection fully current with zero 483s. The CRO quote we'd received was four times what AB7 charged. We've kept the team on retainer ever since.”
How we ran this
The 4-step AB7 deployment pattern.
Every engagement above followed the same four moves. Same shape, different roles.
- 01
Discovery & Diagnosis
Kick-off call, requirements scoping, success-metric definition. We walk away with the role spec and the integration plan.
- 02
Source & Vet
First profiles inside 60 minutes for common roles, 48 hours for niche. NDA-protected, pre-screened, role-fit assessed.
- 03
Onboard & Integrate
IT setup, system access, knowledge transfer, pair work in week one. By day 14, the new seat is operating independently.
- 04
Optimise & Scale
Weekly performance reviews, monthly retros, capacity expansion when ready. 30-day replacement guarantee throughout.
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