Praxis Precision Medicines
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
Qualifications and Key Success Factors
Preferred Qualifications
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.
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!
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
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