[Hiring] Head of Pharmacovigilance @Praxis Precision Medicines, Inc.

Role Description

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

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. The Head of PV owns the pharmacovigilance system and the team that runs it.

The function is organized in two parts:

• Pharmacovigilance for programs in clinical development led by the PV Clinical Development Lead.
• Pharmacovigilance for commercial products held directly by the Head of PV.

The Head of PV is accountable for:

• The pharmacovigilance system as a whole.
• Setting standards and governance.
• Final safety decision-making for the company.

The role is accountable, not advisory, and includes:

• Owning the pharmacovigilance system and compliance.
• Defending conclusions and submissions to health authorities.
• Collaborating with various departments for comprehensive safety oversight.

Qualifications

• Physician (MD, DO, or non-US equivalent).
• Minimum twelve years of pharmacovigilance experience.
• Proven track record of building and leading a pharmacovigilance department.
• Experience leading through senior direct reports.
• Demonstrated ownership of safety strategy.
• Demonstrated senior medical judgment.
• Experience chairing or running a safety governance body.
• Direct working knowledge of IND safety reporting and postmarketing reporting.
• Working knowledge of ICH guidelines and 21 CFR regulations.
• Comfort working with AI in a regulated process.
• Excellent oral and written English communication skills.
• High integrity and ability to bring out the best in others.
• Demonstrated strategic and critical thinking skills.

Requirements

• Clinical practice background in neurology, epilepsy, psychiatry, pediatrics, or rare disease.
• Direct accountability for postmarketing pharmacovigilance through a first commercial launch.
• Experience transitioning pharmacovigilance activities from an outsourced vendor to an in-house model.
• Experience implementing and validating a safety database.
• Additional advanced degree: PhD or MPH.

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
• 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

Company Description

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. Our core values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business.

We are 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.