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 the human review step is resourced adequately, since that review is the control that makes the AI design defensible, and monitor cases per reviewer per day as a capacity metric with a defined threshold for adding capacity.
• Manage the database vendor as a critical supplier, including qualification, audit, and contractual notification of model or configuration changes.
• Set the PV Operations Lead’s execution authority in writing, so operational decisions are made without seeking permission on detail.

Cross-Functional Leadership

• Provide expert safety guidance across the organization to inform benefit-risk evaluation and development strategy.
• Develop and deliver pharmacovigilance training to ensure company-wide understanding of safety responsibilities.

Qualifications and Key Success Factors

• Physician (MD, DO, or non-US equivalent).
• Minimum twelve years of pharmacovigilance experience, with substantive experience in both the clinical trial and the postmarketing settings.
• Proven track record of building and leading a pharmacovigilance department spanning clinical development and commercial products, evidenced by a specific build the candidate personally led: hiring, quality system, database implementation or transition, and inspection preparation.
• Experience leading through senior direct reports, including delegating a substantial area of the function while retaining accountability for its outcomes.
• Demonstrated ownership of safety strategy, evidenced by a development safety plan the candidate shaped or a safety position they constructed and defended.
• Demonstrated senior medical judgment: a benefit-risk determination the candidate constructed, had challenged by a regulator or governance body, and defended; and signal adjudication including at least one signal decided to refute.
• Experience chairing or running a safety governance body, with responsibility for the integrity of the decisions taken in it.
• Experience in direct health authority interactions on safety matters, including inspections.
• Direct working knowledge of IND safety reporting under 21 CFR 312.32 and postmarketing reporting under 21 CFR 314.80, including current electronic submission requirements.
• Working knowledge of ICH E2A, E2B(R3), E2D, E2F, E6(R3), EU GVP modules, and 21 CFR Parts 11, 312, and 314.
• Comfort working with AI in a regulated process, and the ability to critically evaluate AI-generated narratives, coding, and causality proposals rather than accept or reject them wholesale.
• Excellent oral and written English communication skills.
• High integrity and the ability to bring out the best in others, intellectually and interpersonally, on a cross-functional team.
• Demonstrated strategic and critical thinking skills, and the ability to exercise judgment and address complex problems across multiple programs.

Preferred Qualifications

• Clinical practice background in neurology, epilepsy, psychiatry, pediatrics, or rare disease, and experience in neuroscience clinical research.
• Direct accountability for postmarketing pharmacovigilance through a first commercial launch at a small or mid-size company.
• Experience transitioning pharmacovigilance activities from an outsourced vendor to an in-house model.
• Experience implementing and validating a safety database, including the 21 CFR Part 11 assessment.
• Additional advanced degree: PhD or MPH.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

 

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary in the range listed below.  This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.