Head of Pharmacovigilance
praxisprecisionmedicines
1 month ago
Full-time
On-site
United States - Remote
$378,000 - $420,000 USD yearly
Leadership
Moneyboard classification: Published base at/above threshold
Reported USD annual base: $378,000–$420,000
Original source: Greenhouse
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, s
Reported USD annual base: $378,000–$420,000
Original source: Greenhouse
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, s