For small organizations, building a PV department from the ground up can be an exercise of trial and error, frustrating and costly. Being in growth mode means that there is not much time to anticipate and plan, as multiple high priorities compete for attention. The right architecture for a PV organization will shorten the long road to inspection readiness, and minimize the risks of PV findings during the dreaded preapproval inspection… So where should you start?
Size does not matter, at the beginning…
Your business model is very likely going to be an outsourced model, with many PV activities delegated (case processing, coding, part of signaling…) and some core competencies kept in house (signaling, benefit-risk assessment, final decision on coding, reporting, …). Four roles are key to start, whether the company handles 100 or 1000 SAEs per year, to provide stability to the edifice you are building.
It will always be slower than you think
The current market for experienced PV individuals is tight. Most big and small companies are concentrating in Boston or San Francisco, with a large number of innovative biotechs experiencing high demand for PV roles. The length of PV experience is not only what matters. To work in a small biotech, one needs a few specific skills such as being hands-on, possessing a teamwork mindset and intellectual agility, as well as creativity traits and the ability to work at a fast pace with many (many) irons in the fire. Working in a large pharma cannot always prepare for what life is in a growing biotech. All this reduces further the pool of talented candidates and hiring can take months and months. Start early, do not waste time.
Do not walk on your head…
Do not make the mistake to allocate one headcount for the Head of PV and wait to see what happens next. If you do so, you will force a senior experienced PV Leader to chose between operational activities (review of cases, triage, contribute to the Study Management Teams, etc.) and strategic contributions. Guess what will always happen: the operational priorities will always take precedence because of the running timelines, and the strategic thinking time will be crunched to almost nothing. The result will be frustrating, demotivating and will be a lost opportunity. Give this PV head a better chance to be successful by immediately allocating budget for additional headcounts. Get a team.
The PV build will be as solid as its foundations..
Four roles are key to start a PV organization.
1 Head of PV: visionary, strategic, decision maker, experienced and hands on as needed;
1 Safety Physician: applying medical safety science and methodology to the individual cases, aggregate reports and signaling, interacting closely the outsourced PV vendor;
1 Safety Manager: hands on operational and critical help for moving the case reports forward with the service provider;
1 Responsible for PV Compliance, Training and Vendor Oversight: the intense needs for specific PV expertise on Quality, Compliance and Training must be fulfilled early. There are so many SOPs to write and to implement, and so many things that can go wrong in a outsourced model.
When growing further, you can add new wings to your structure: a Project Management resource (there will be so many transformations down the road) and an IT/Database Manager (PV database management and safety queries are the founding blocks of PV activities and Risk Management).
With this base, your organization will be prepared for future challenges, will boost the teams’ efforts and will minimize the pre-approval inspection PV risks. An early investment in a strategic PV organization will always provide invaluable services and will smooth the long ride to deliver new therapies to patients in need.
JP Clement, MD