Safety & Pharmacovigilance (PV)

What are you doing to understand and ensure the safety of your therapeutic?

Is your therapeutic safe? That’s the primary concern of the FDA and other regulators. Yes, efficacy is important, but the consequences of uncovering a safety concern late in development are disastrous. Failure to plan strategically can cause delays in development and approval, impact uptake, or get your products pulled from the market.

Most early biotechs face multiple challenges when building a Safety & Pharmacovigilance (PV) function:

  1. Resources are limited, and safety deprioritized, which often necessitates individuals complete tasks outside their skillset, i.e., the CMO monitoring individual case reports.
  2. Lack of knowledge around safety throughout the development lifecycle, especially in the early stages, inhibits the realization of safety as a value-driver.
  3. The talent pool for people with both a strategic and tactical PV skillset is limited. The market is very competitive, and hiring and retaining the right people at the right time and within budget constraints is challenging.

Safety & PV are often not seen as a priority until late in the clinical development process (wrongly assuming you only need safety infrastructure when you are in the post-marketing world) or until there are significant safety-oriented fires to put out.

Furthermore, getting ahead of safety risks allows you to build your clinical program toward strengths and can identify new opportunities or patient populations that should be a focus.

It’s much more effective to begin with a safety and PV philosophy in mind from the start. This enables you to build a scalable PV system, be proactive rather than reactive when there is a potential safety issue, and may also help inform clinical, medical, and regulatory strategy.

By working with SSI Strategy's experienced former Heads of PV and PV Operations, we can help you de-risk your asset. We have MDs with experience reviewing case reports, evaluating product safety, and performing signal analysis, as well as PV Operations experts that can set up the appropriate and compliant infrastructure to monitor and assess safety on an ongoing basis. Our team can also help you create a PV strategy and augment your existing team.

We can also help you navigate the complicated PV regulatory requirements expected of an organization across the lifecycle – balancing and delivering on both the medical and operational skillsets needed to deliver these requirements, but NOT overselling the functional need as a Contracted Safety Organization may be incentivized to do.

An agile PV support team

Your safety & Pharmacovigilance needs ebb and flow. Hiring full-time employees with specialized skillsets only required in short sprints until key milestones are met may not be an efficient use of resources. And individual contractors aren’t always considering the entire safety picture and are focused on tactical activities. Contracted Safety Organizations (CSO) often don’t take the strategic and tailored approach you need to understand the safety profile of your product.

We typically work in concert with a CSO but are not their replacement - often, we are managing and guiding the CSO in designing and creating a more fit-for-purpose safety infrastructure for an organization.

Our model is built around an agile approach. We bring in the exact skillsets you need at the right time. Instead of trying to find someone that can adequately fulfill disparate skill sets, you can get access to experienced experts for your exact needs.

We provide Pharmacovigilance services through clinical development/translational, launch, and post-marketing:

Medical Support

  • Interim PV leadership
  • Strategic oversight and design of PV system
  • Routine and targeted Signal assessment and analysis
  • Product safety evaluation throughout the lifecycle
  • Review of individual case reports


  • PV system design and strategy
  • PV system gap and risk assessment and remediation
  • PV procedures: mapping, development, implementation
  • CSO vendor oversight and management
  • Authoring of aggregate reports
  • Inspection readiness

As your funding fluctuates and your safety needs progress and change, we’ll work with you to meet milestones and de-risk your organization through proper planning, management documentation, and execution. Our team members embed in your team to ensure that no safety data gets missed to ensure patient safety and regulatory compliance.

Whether you are standing up a PV organization, launching a new product, preparing for inspection, or navigating a merger, we can help.

Don’t go it alone. We are here for you.

Let’s talk.

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