What does a fractional VP Pharmacovigilance actually do? A complete guide

A Series A biotech with 12 employees and a Phase 1 CNS compound asks their investor: do we need a VP Drug Safety? The investor replies: at your size, a full-time VP is $350,000 in salary before equity. You don't need that. What you need is a fractional VP PV. The CMO nods and immediately wonders: what does that actually mean? Is it just a part-time consultant? How does it differ from a CRO? Who is accountable?

What the role actually is

A fractional VP Pharmacovigilance is a senior drug safety professional who serves as the functional head of pharmacovigilance for your company on a part-time, retained basis. They are not a consultant who gives advice. They are an operational leader who owns the PV function — which means they are named in your PSMF, attend your safety committee, sign off on aggregate reports, and represent your company at authority meetings.

The "fractional" part means they serve multiple clients, which is what makes the economics work. A senior VP PV with 20 years of experience at Big Pharma costs $350-450K in salary. On a fractional model, that same expert serves 4-6 small pharma clients, each paying a monthly retainer of $8-15K — depending on program stage and service scope. You get senior expertise at a fraction of the cost, and the expert maintains a sustainable practice.

How it differs from a CRO

This is the most common source of confusion. A CRO provides pharmacovigilance services — ICSR processing, aggregate report writing, safety database management — as deliverables. You are a client receiving outputs. A CRO does not embed in your organisation, does not attend your executive team meetings, and is not named in your PSMF as a responsible person.

A fractional VP PV is embedded in your organisation as a functional leader. They set the PV strategy, manage any CRO relationships on your behalf, own the regulatory relationships, and provide the human accountability that regulators require from a named responsible person. Many fractional VP PV arrangements include a small operational team — a safety associate or ICSR processor — so the VP has the support they need to execute, not just advise.

What a fractional VP PV does week to week

In a typical month, a fractional VP PV for a Phase 1-2 company will:

• Review and sign off on all SUSAR assessments — typically 0-3 per month at Phase 1
• Attend the safety committee meeting (monthly or quarterly) and chair the safety review
• Review and update the Investigator Brochure safety sections at each scheduled revision
• Manage the annual DSUR preparation and submission
• Respond to authority questions about safety topics within the IND or CTA
• Conduct a quarterly PV system review — training records, SOP currency, ICSR tracking status
• Maintain and update the PSMF (or PSMF-equivalent for pre-MAA programs)
• Provide ad hoc guidance on safety questions — protocol amendments, dose escalation decisions, lab finding interpretations

When fractional PV makes sense

Fractional VP PV is the right model for: companies at Pre-IND through Phase 2 with one or two investigational compounds; companies with one marketed product in a limited number of territories; and companies transitioning from CRO-managed PV to in-house and not yet ready for a full-time head.

It is not the right model for companies with 10+ marketed products, post-approval products with high spontaneous report volumes, or companies with regulatory commitments that require daily PV operational presence. At that scale, a full-time VP PV — or a hybrid of in-house and fractional support — is more appropriate.

Nimble PV provides fractional VP Drug Safety with named accountability in your PSMF, available for authority meetings, and onboarded in 5-10 days. Talk to Vera at nimblepv.com.