Head of Pharmacovigilance

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Reporting to the Senior Vice President, Head of Clinical Sciences, the Head of Pharmacovigilance (PV) is a physician who builds and leads Praxis’s in-house pharmacovigilance function across clinical development and commercial products. Praxis is building its pharmacovigilance system in-house rather than outsourcing it, and is using an AI-enabled safety database to create an efficient case-handling process. The Head of PV owns that system and the team that runs it.

The function is organized in two parts. Pharmacovigilance for programs in clinical development is led by the PV Clinical Development Lead, who reports to the Head of PV, leads a dedicated clinical trial safety team, and carries day-to-day medical safety oversight of the clinical-stage portfolio. Pharmacovigilance for commercial products is held directly by the Head of PV, who is personally accountable for postmarketing safety surveillance, reporting, and benefit-risk, and who directly leads the commercial-product Medical Reviewer and PV Scientist. The PV Operations Lead supports both parts of the function. Across both, the Head of PV is accountable for the pharmacovigilance system as a whole, sets the standards and governance that the two parts operate under, and is the final safety decision-maker for the company.

The safety database will already be built and validated. What this role takes on is a system that needs enhancement and modification as new products advance and launch, a quality system that has to keep pace with it, and a team that has to be assembled and qualified. The Head of PV understands pharmacovigilance operations well enough to direct them and to judge whether they are working, but does not carry them personally; the PV Operations Lead is engaged for that and is involved throughout.

The role is accountable, not advisory. The Head of PV owns the pharmacovigilance system, expedited and periodic reporting compliance, the conclusions and submission of the aggregate safety reports, and the integrity of the signal management process, and defends them to health authorities. As the senior safety physician, the Head of PV personally holds the medical determinations that sit at the center of the function for commercial products, and holds final authority over those made for clinical development programs: benefit-risk, signal adjudication, and complex case causality. The Head of PV works collaboratively with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, Data Science, and Commercial to ensure comprehensive safety oversight of Praxis products.

Primary Responsibilities

Leadership of the PV Function