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 Lead the pharmacovigilance function as a whole, accountable for the pharmacovigilance system, its quality, and its compliance across clinical development and commercial products. Directly lead pharmacovigilance for commercial products, including the commercial-product Medical Reviewer and PV Scientist, holding personal accountability for postmarketing safety surveillance, expedited and periodic reporting, signal management, and benefit-risk. Oversee pharmacovigilance for clinical development programs through the PV Clinical Development Lead and the clinical trial safety team reporting to that role: set expectations, standards, and escalation criteria; review the safety positions taken; and retain final authority over program-significant safety decisions. Ensure the clinical development and commercial parts of the function operate as one system, with a single quality system, a single safety database, consistent medical judgment across both teams, and a clean handover of safety accountability as products move from development to market. Senior Medical Determinations Make and articulate the benefit-risk determination for each commercial product in aggregate reports, regulatory correspondence, and labeling discussions, and approve the benefit-risk position for each clinical development program prepared by the PV Clinical Development Lead. Adjudicate validated signals, deciding whether the evidence supports a causal association, including decisions to refute, and determine sponsor causality on complex and program-significant cases escalated by the commercial-product Medical Reviewer or by the PV Clinical Development Lead for clinical trial cases. Set expectedness determinations where the medical question is ambiguous, and set the medical position on Reference Safety Information and US label safety content. Approve the medical content of PADERs and PBRERs, including the interpretive and benefit-risk sections, and approve the DSURs prepared under the PV Clinical Development Lead. Set and monitor the escalation criteria that route a case, signal, or program-level safety question to the Head of PV, and ensure escalation happens on time rather than at the next scheduled meeting. Supervise the commercial-product Medical Reviewer directly and the clinical trial medical reviewers through the PV Clinical Development Lead; set the medical review criteria; and calibrate consistency of medical judgment across both teams. Building the Function Design and stand up the pharmacovigilance operating model in collaboration with the PV Operations Lead, across clinical and postmarketing settings, including the interfaces with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and Commercial. Recruit, onboard, develop, and retain the PV team, including the PV Clinical Development Lead, and define competencies, training curricula, and qualification evidence for each role. Establish and maintain the pharmacovigilance quality system: SOPs, work instructions, safety management plans, safety data exchange agreements, deviation and CAPA handling, and compliance metrics. Own the move of clinical trial safety activities in-house, including scope, sequencing, validation gates, and vendor exit. Safety Strategy & Governance Define the safety strategy for each product and program, including the risk management approach and the events of special interest; for clinical development programs, set the strategy with the PV Clinical Development Lead and ensure strategic safety input reaches clinical development plans and study designs. Chair the Signal Management Committee, own the integrity and cadence of the signal management process, and ensure every signal decision is documented with its rationale. Lead the development and implementation of risk management and risk mitigation strategies. Approve the safety-related sections of key documents, including protocols, Investigator’s Brochures, INDs/CTAs, DSURs, DSMB/safety committee charters, and postmarketing labeling and risk management documents; the PV Clinical Development Lead authors and reviews these for clinical development programs. Regulatory Accountability & Inspection Readiness Accountable for expedited and periodic reporting compliance across regions, including IND safety reporting under 21 CFR 312.32 and postmarketing reporting under 21 CFR 314.80. Own the conclusions and the submission of aggregate safety reports. Lead safety interactions with FDA and other health authorities, including information requests, advisory meetings, and inspections. Ensure the PV system is inspection ready at all times. The PV Operations Lead executes; the Head of PV is accountable for the outcome. The AI-Enabled Operating Model Ensure the safety database is run as a controlled business system: requirements, configuration decisions, change control, user access, and the validated state. Day-to-day administration sits with the PV Operations Lead. Define the AI governance framework: documented intended use per AI function, acceptance criteria, human-in-the-loop control definition, production performance monitoring, and the trigger for re-review when performance drifts. Ensure t