Pharmacovigilance

A pharmacovigilance system stretched thinner with every stage of growth

About

In most small and mid-size pharma and biotech companies, a Head of Safety or a small team already runs pharmacovigilance. What has not kept pace is the system around them. As products, markets, and submissions multiply, the processes, tools, and resourcing stay roughly where they were at an earlier, smaller stage of the company. The result is a structure carrying more than it was built for. We resize it to the workload it is actually carrying.

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Typical clients:

Pre-MAA and building your first PV system

Preparing for commercial launch

Post-marketing and optimising what exists

Growing organisation through M&A

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From the Trenches

Common Challenges we Solve

The Challenge

PV Ecosystem Design

Processes were added one at a time, by different people, at different stages of growth. What looks fine piece by piece creates gaps and duplication once an inspector looks at it as a whole.

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The Solution

One PV ecosystem, sized to your current pipeline. Processes, technology, and quality oversight connected end to end, with clear ownership for each part.

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The Challenge

Transition to Commercialisation

The move from clinical to commercial brings a full set of new regulatory obligations on a compressed timeline, often before the team or the system is ready to carry them.

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The Solution

A commercial-stage PV structure built ahead of launch, not during it. The roles, processes, and reporting lines a marketed product requires, in place before day one.

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The Challenge

PV Vendor Selection & Management

A vendor mismatch rarely shows up during selection. It shows up afterwards, in missed case-processing timelines, inconsistent data, or costs that outgrow the original quote.

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The Solution

A selection and governance process built before the contract is signed, not after a mismatch is discovered. Defined criteria, defined oversight, and reporting and escalation lines that match how your team actually works.

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The Challenge

PV Platform Migration

Today's safety platform is not just a case database. It carries workflow rules, signal detection logic, and reporting templates built up over years of use. A change of system risks losing or misconfiguring that functionality alongside the case data itself, often invisible until the new platform is already live.

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The Solution

A migration plan built around functional continuity as well as data integrity: workflows, business rules, and reporting templates mapped and tested before cutover.

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The Challenge

PV Sourcing Strategy

Every provider added to the PV ecosystem, a CRO, a technology platform, a regional affiliate, was a decision made in isolation. Nobody designed the whole. The result is duplicated cost and quality that varies by provider.

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The Solution

A sourcing strategy that treats the ecosystem as one system. Clear lines between what stays in-house and what does not, service providers chosen against defined criteria, and technology that fits the operating model. The result is lower cost and consistent quality.

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The Challenge

PV Sourcing Strategy Under Structural Change

An acquisition or a shift in company structure exposes a sourcing setup built for a different organisation. Contracts, headcount, and technology no longer match what the business now needs, and there is no time to start from scratch.

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The Solution

A sourcing strategy built to flex, not to be rebuilt each time. Provider relationships, staffing balance, and technology choices reviewed against the new structure, with decisions made before the gap becomes an inspection finding.

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