Navigating the pharmacovigilance lifecycle
See what often matters at each lifecycle stage and how UBC can help you stay ahead.
Explore the lifecycle mapNavigating the pharmacovigilance lifecycle
See what often matters at each lifecycle stage and how UBC can help you stay ahead.
Explore the lifecycle mapPriorities at pre-submission stage
Most clinical programmes rely heavily on CROs. That works well - until nobody’s completely sure who owns what. The earlier you agree how decisions are made, the less you’ll need to unpick when timelines become tighter. Most teams don’t need a bigger PV function yet. They need stronger foundations.
= High priority- Discovery (high priority)Could a new PV lead or quality head make sense of the systems in place?
- Vendor (high priority)How will you maintain oversight as CROs run more of the day-to-day PV operations?
- InspectionAre you ready for a potential pre-submission inspection? (e.g. BIMO, sponsor visit)
- ScalingHow will your oversight hold up as the program grows toward filing?
- DiligenceWill your PV data stand up to M&A or out-licensing diligence if required?
- LaunchNot a priority at this stage.
Pre-submission engagement journey
PV systems evolve gradually. New products are added, new markets are entered, processes adapt. Over time, complexity accumulates. Risks emerge in the gaps between process, responsibilities, and assumptions. Sometimes the most valuable thing is understanding where you stand before somebody else asks.
- 1PV system health check
An honest read on what's actually working, not just what SOPs say. This is the baseline everything else builds from.
- 2CRO and vendor oversight framework
Where accountability gets put in writing: who owns what across your CROs and vendors, and the SDEA portfolio to match.
- 3DSUR authoring infrastructure
DSURs come around every year regardless. This sets up the infrastructure to produce them on schedule, not in a scramble.
- 4Signal management readiness
Most pre-submission-stage signal processes run through a CRO. This brings visibility into what's actually being caught, and how.
- 5Strategy & advisory retainer
Not every decision needs a full engagement, some just need someone senior on the call. A lighter retainer for those moments.
Priorities at Submission stage
Launch has a habit of exposing decisions made much earlier. Most teams focus on submission. Regulators look at the operating model behind it. The closer you get to launch, the harder structural decisions become to change.
- Discovery (high priority)Have you had an honest look at the gaps between where you are and what filing requires?
- VendorWith CRO transitions, a new safety call centre and a new SDEA framework all in motion, is anything at risk of slipping?
- InspectionAre you doing readiness work now, even though your first GVP inspection is likely a stage away?
- Scaling (high priority)Is your PV counsel strong enough for the board and investor scrutiny building around launch?
- DiligenceCould partnership or licensing talks around approval put your PV data under closer scrutiny?
- Launch (high priority)Is your PV system ready to make the jump from clinical to commercial?
Submission engagement journey
Submission PV work rarely runs in a straight line, and you may not need every step below. What matters is closing the gap between where your system is today and what it needs to withstand at launch — from the first honest assessment through to standing on your own once the inspection clock starts.
- 1PV system gap analysis
A structured read against GVP and FDA expectations, not a generic checklist. This is where the real launch-readiness gaps get named, not guessed at.
- 2PV system build (or rebuild)
Whatever the gap analysis surfaced gets built here — SOPs, systems, roles, all the structural pieces launch actually depends on.
- 3PSMF buildout
The master file regulators expect at filing. It has to hold up before marketing authorization, not get assembled after the fact.
- 4Risk management plan & REMS authoring
One document, years of downstream obligations. Getting it right here saves a lot of rework once the product is on the market.
- 5Aggregate reporting infrastructure
The DSUR-to-PSUR transition catches teams out more than they expect. This sets the cadence up before it has to run for real.
- 6Submission readiness review
A T-90 days dry run — a full rehearsal of the system under pressure, while there's still time to fix what doesn't hold.
- 7Inspection readiness sprint
Post-filing, before the calendar starts. The last real chance to close gaps before an inspector finds them first.
Priorities at first commercial stage
Launch is a milestone. Running a commercial safety function is a different discipline altogether. Many processes that worked well during development come under much greater scrutiny once a product is on the market. Growth doesn’t usually create new problems - it exposes the gaps that were already there.
- Discovery (high priority)Is what you built for filing still the right fit for day-to-day operations?
- Vendor (high priority)Can your CRO oversight keep up as post-marketing reporting volume grows?
- Inspection (high priority)Are you ready for a first GVP/PV inspection in these first 12–24 commercial months?
- Scaling (high priority)Are your PV headcount needs outpacing what you can actually hire?
- DiligenceWould your PV function hold up if partner or acquisition interest picked up post-launch?
- LaunchCould an indication or geographic expansion trigger a fresh round of launch-shaped work?
First commercial engagement journey
Outsourcing relationships are usually stood up fast, around commercial launch, and oversight gets built after the fact. Once a vendor is embedded in your safety data flow, gaps are hard to see from the outside — until a regulator, an audit, or a signal asks a question your own reports can't answer.
- 1First-year PSMF maintenance
PSMF Live — the document an inspector reads first. Keeping it current from day one avoids a scramble the first time someone asks to see it.
- 2Aggregate reporting cadence
PSUR, PBRER, PADER — different names, one operating model. This makes the cadence defensible instead of reactive.
- 3Signal detection program operations
Most signal processes are still CRO-driven at this point. This moves detection in-house enough that you can see it, not just receive a report on it.
- 4Vendor oversight optimization
The SDEA framework gets tested by live data now, not assumptions. This matures oversight to match what's actually flowing through it.
- 5Inspection readiness on-call
Surge capacity for the inspection that's coming, not a hypothetical one. Support that's there when the notice actually lands.
- 6Strategy & advisory retainer
Ongoing senior counsel through the highest-stakes period the company has faced yet. Not a one-off call, a standing one.
Priorities at mature commercial stage
Most organisations don’t redesign their PV model overnight. It evolves one product, market and acquisition at a time. Complexity doesn’t usually come from having more products. It comes from having more ways of doing the same thing. The strongest operating models are reviewed before growth exposes their limits.
- Discovery (high priority)Would a periodic governance review surface drift that day-to-day monitoring alone would miss?
- Vendor (high priority)Can you govern multiple vendors consistently at portfolio scale?
- InspectionEven with a steady inspection cadence, is your readiness still as sharp as it should be?
- Scaling (high priority)Have you shifted from 'do we have enough seniority' to 'do we have the right governance model'?
- Diligence (high priority)Is your PV data ready to withstand M&A diligence, whichever direction it comes from?
- LaunchCould a new indication or label expansion still create a fresh pocket of launch-shaped work?
Mature commercial engagement journey
There comes a point when operational support is no longer enough. Board discussions, regulator interactions, partnership negotiations and safety concerns require a different level of experience — not because the team isn't capable, but because the stakes have changed. Recurring inspections test whether that experience holds up under scrutiny.
- 1Multi-product PV governance review
A check on whether the operating model built for one product still fits a growing portfolio, or whether it's quietly falling behind.
- 2Cross-portfolio signal management
Coordination across products, not duplication of the same work five times over. One view instead of five separate ones.
- 3Vendor consolidation strategy
Fewer vendors, stronger oversight of each one. Consolidation that's deliberate, not just cost-driven.
- 4Aggregate reporting at portfolio scale
A shared calendar, clear owners, a reviewer rotation that actually holds. Reporting that scales with the portfolio instead of straining under it.
- 5Strategic counsel on indication expansion
Lifecycle management decisions made with someone who's seen where these choices lead, not just what they cost today.
- 6M&A readiness / diligence support
Whether a deal is already in motion or just a possibility worth preparing for, the PV picture needs to hold up under someone else's scrutiny.
- 7Strategy & advisory retainer
A named QPPV and deputy on retainer — senior accountability built in, not bolted on when it's asked for.
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