Senior-level PV.
No full-time hire.
Built for biotech.
Nimble PV is your Fractional VP of Drug Safety — AI-powered monitoring with named human experts. We scale with your program from Pre-IND to post-approval.
The gap no one talks about
Small pharma can carry the same PV obligations as Big Pharma — with a fraction of the resources.
- ✗No PV system according to local regulations
- ✗Junior hire can't satisfy regulators
- ✗$350K/yr VP hire for a single Phase 1 asset
- ✗CRO deliverables not tailored to company needs
- ✗Inspection notice lands — three consultants can't save you
- ✓PV systems established as required
- ✓Named Fractional VP accountable to your PV system
- ✓Fraction of full-time VP cost — scales with your program
- ✓Full process visibility, AI-powered monitoring
- ✓Inspection-ready from day one — 24h mobilisation
We got our first EMA inspection notice in 2023. We had no well established PV system, no signal log. Nimble PV had us audit-ready in six weeks.
— CMO, Series B Oncology Biotech (Phase 2)
We cover every stage of your drug's journey
PV requirements evolve as your program progresses. Nimble PV scales with you — from first-in-human to post-market surveillance.
Not sure what you need at your current stage?
How Nimble PV works
Three layers that work together so your drug program stays compliant, documented, and ready for any authority.
AI Monitoring Layer
Continuous signal detection, literature surveillance, and regulatory change monitoring — 24/7, zero gaps.
Human Expert Oversight
Every AI output is reviewed by a named pharmacovigilance expert. You always know who is responsible.
Fractional VP Leadership
Your designated VP of Drug Safety — available for regulatory meetings, board updates, and authority submissions.
Full-spectrum PV.
Modular by design.
Pick one service or the whole stack. Scale up or down as your program evolves.
| Full-Time VP $300–400K/yr | Big CRO $50K+ setup | Nimble PV Fractional | |
|---|---|---|---|
| Named expert accountable in PSMF | ✓ | – | ✓ |
| Scales with your program stage | – | – | ✓ |
| 24/7 AI monitoring layer | – | – | ✓ |
| Onboard in days | – | – | ✓ |
| Inspection mobilisation in 24h | ✓ | – | ✓ |
| Cost-effective for Phase 1–2 | – | – | ✓ |
| Setup fee | $0 | $50K+ | $0 |
Fractional VP Drug Safety
Senior safety leadership on a part-time model. Named expert, real accountability — without the full-time headcount.
ICSR Processing
End-to-end case processing: MedWatch, CIOMS, EudraVigilance. On time, every time.
Aggregate Reporting
PSUR, PBRER, DSUR preparation and submission support. Audit-ready on your timeline.
Signal Detection
AI-powered disproportionality analysis plus expert-validated assessment. Catch signals early.
Risk Management
EU-RMP, US REMS, and risk minimisation strategy. Structured for regulators, designed for your team.
Regulatory Intelligence
Proactive GVP and ICH guideline monitoring. No surprises, no scrambling — just clear guidance.
PV System Setup
SOPs, safety database selection, team training. Everything to get your PV system off the ground.
Not sure where to start?
Tell Vera your phase and indication. She'll tell you exactly what you need.
Your AI pharmacovigilance expert.
Available right now.
Vera is trained on GVP Modules I–XVI, FDA 21 CFR, ICH E2A–E2F, and the specific realities of small pharma programs. She answers regulatory questions instantly — and escalates to a human expert when your question needs one.
Real experts. Real accountability.
You hire a person, not a helpdesk. Every client gets a named VP — personally accountable, listed in your PSMF.
VP Pharmacovigilance
30 years in drug safety
30 years in drug safety. Pharmacovigilance at a top-10 global pharmaceutical company ($20B+ annual revenue), responsible for a PV system covering 60+ marketed products across 80 countries. Named responsible person through 30 FDA/EMA inspections/audits with zero critical findings. Expert in GVP Modules I–XVI, PSUR/PBRER submission strategy, and building PV systems from pre-IND through post-approval.
EU QPPV
Senior Advisor · PV Strategy
18 years across drug regulatory affairs and pharmacovigilance. Former Corporate QPPV for a large multinational European specialty pharma group, overseeing PV operations in 32 EU/EEA countries. Led three PSUR Work-Sharing submissions and authored the company's first global RMP. Previously Global Head of Signal Management at a mid-size oncology company, introducing quantitative disproportionality analysis across 8 marketed oncology products.
ICSR Operations & Regulatory Submissions
Senior PV Associate
12 years in ICSR processing, safety database management, and expedited reporting. Processed over 25,000 ICSRs across MedWatch, EudraVigilance gateway, and MHRA Yellow Card. Certified in E2B(R3) and MedDRA coding. Expert in CIOMS I/II forms, 15-day and 7-day expedited submissions, and managing submission timelines during pivotal Phase 3 trials and NDA/MAA filing periods.
What “fractional VP” actually means
- →Named in your PSMF as the responsible person for PV
- →Attends your safety committee and signs aggregate reports
- →Represents your program directly at FDA, EMA, and MHRA meetings
- →Direct line — not a ticketing system or shared inbox
- →24h inspection mobilisation — gap assessment by noon
- →Scales with your pipeline: Pre-IND needs less than Phase 3
Authority meetings from day one
FDA · EMA · MHRA · Health Canada
Former Deputy Head of Pharmacovigilance, EMA
Senior regulatory policy advisor with 16 years at the European Medicines Agency, including serving as Deputy Head of the PV and Risk Management department. Shaped EU GVP Module VI revision and the post-2012 EU pharmacovigilance legislation. Deep expertise in PRAC processes, signal management from a regulator's perspective, and pre-inspection preparation.
Former Head of Drug Safety, FDA CDER
Medical officer with 14 years at FDA's Center for Drug Evaluation and Research, including as Acting Division Director for Pharmacovigilance and Epidemiology. Led multiple post-market safety reviews resulting in label changes and REMS programs. Advised on over 200 NDA and BLA submissions. Provides Nimble PV clients with insight into how FDA reviewers assess safety signals and inspection priorities.
What our clients say
We needed a QPPV and a functioning PV system before our Phase 1 first patient in. Nimble had us ready in 28 days. The process visibility we get is something no CRO has ever given us.
The combination of Vera for day-to-day questions and a named VP for strategic decisions is exactly what a virtual pharma company needs. It's like having a full PV department.
When our EMA inspection notice arrived I called my Nimble VP at 7am. By noon we had a gap assessment and a 90-day remediation plan. That kind of response is why we renewed.
Frequently asked questions
Can't find your answer? Ask Vera directly.
Your drug program deserves
senior PV leadership.
Start with a free 30-minute assessment. No commitment, no sales pitch — just honest answers about what your program needs.