Head of Pharmacovigilance

The role

The Head of Pharmacovigilance is a physician who builds and leads the in-house pharmacovigilance function for clinical development and commercial products. This person owns the pharmacovigilance system, manages the team, and serves as the final safety decision-maker.

What you will do

• Lead the pharmacovigilance function and its quality and compliance
• Direct pharmacovigilance for commercial products
• Oversee pharmacovigilance for clinical development programs
• Make benefit-risk determinations for commercial products and clinical programs
• Adjudicate validated signals and determine sponsor causality
• Set medical positions on Reference Safety Information and US label safety content
• Approve medical content of PADERs, PBRERs, and DSURs
• Design and stand up the pharmacovigilance operating model
• Recruit, onboard, develop, and retain the PV team
• Lead safety interactions with FDA and other health authorities

Required qualifications

• Physician (MD, DO, or non-US equivalent)
• Minimum twelve years of pharmacovigilance experience
• Substantive experience in both clinical trial and postmarketing settings
• 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
• Experience in direct health authority interactions on safety matters
• Direct working knowledge of IND safety reporting under 21 CFR 312.32 and postmarketing reporting under 21 CFR 314.80
• Working knowledge of ICH E2A, E2B(R3), E2D, E2F, E6(R3), EU GVP modules, and 21 CFR Parts 11, 312, and 314
• Excellent oral and written English communication skills

Nice to have

• Clinical practice background in neurology, epilepsy, psychiatry, pediatrics, or rare disease
• 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
• PhD or MPH

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans to personalize coverage
• Dollar-for-dollar 401(k) match up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Extremely flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.