SSI Strategy: Optimizing Pharmacovigilance with Innovation
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SSI Strategy: Optimizing Pharmacovigilance with Innovation

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Adam Schwartz, President, SSI StrategyAdam Schwartz, President
Historically, many Life Science organizations treated the Safety/ Pharmacovigilance (PV) function as a costly function that was necessary for compliance and risk avoidance purposes, but provided limited value back to the business. In these cases, safety was often left in a silo to operate independently from not only business strategy, but also scientific and medical functions, with safety leadership only invited to key meetings if a safety related issue was on the agenda.

SSI Strategy (SSI) is a global boutique Life Sciences consulting firm that is focused on the needs of the medical office including Initial caps. Safety, Medical Affairs, and Clinical Development. SSI views the safety function within Life Science organizations, including clinical safety, PV, and device vigilance as strategic business drivers and an advantage for companies that treat it as such. SSI’s President, Adam Schwartz says, “Our view of the safety function is that it can add significant value to the business by generating scientific insights, driving innovation in scientific analysis, and building trusted relationships with health authorities.” Moving forward, SSI sees the future of the PV function further integrating with other business functions and becoming a strategic advantage for companies as data becomes more readily available through integrated digital health technologies.

For PV leaders to provide maximum value to their businesses they need to continually invest in improving the PV System. SSI believes that leaders need to continually balance between investing in developing innovations to increase insights, improving efficiency to manage costs, and reducing risk by verifying consistent compliance. “We find that helping leaders assess their safety systems to identify the current state and prioritize their needs across the resource constraints of innovation, efficiency, and risk reduction can assist PV teams in proactively maximizing the value they can provide to the business. In addition, this helps ensure that leaders have a clear vision for their use of new innovations,” explains Adam Schwartz.

SSI combines the scientific acumen of experienced medical executives with the expertise of business consultants to support the strategic needs of the Medical Office


Today, in order to gain a competitive edge, Life Sciences companies are sometimes deploying emerging technologies without a vision of what they want to accomplish with the tech-based implementation, which poses a major challenge. “Firms need to set an overarching goal to better define future objectives and make the right decisions to achieve them,” adds Schwartz. Additionally, large companies often find it difficult to gain insights from their PV and safety data and share that across the organization. On the contrary, small to medium-sized companies face problems that revolve around the maintenance of compliance and efficiency as they rapidly grow. In order to address such organization-specific challenges in the industry, SSI initiates customer engagements by gaining an understanding of their vision for the future and some of the unique problems they are managing. In some cases, SSI becomes an extension of the client’s team, and in others, they analyze a customer’s specific problems through interviews or documentation reviews, before offering recommendations to resolve the issues. Additionally, SSI provides operational support to businesses that need help in streamlining overall business activities.

One example of SSI’s work is their collaboration with a client that was struggling to align their PV and Information Technology ( IT) departments. This restricted the client from devising a strategy that could meet near-term product development objectives. With SSI’s assistance, the client was able to align the PV and IT teams along with gaining an understanding of their vision and strategies for the two departments from an overall business perspective. In addition, SSI helped the firm develop a 3-5 year roadmap with inputs and insights from both, PV and IT to effectively define future goals.

Going forward, SSI plans to further expand their existing global footprint in New York, New Jersey, Boston, San Francisco, and London to support their clients. “It is crucial for Life Science organizations to have a clear idea and understanding of what they plan to accomplish with a new technology or innovation, and we provide an efficient way to realize business requirements, strategies, and future roadmaps, with our consulting services,” concludes Schwartz.