Lead the pharmacovigilance function as a whole, accountable for the safety system, quality, and compliance across clinical development and commercial products.
Directly manage the commercial-product PV team, and oversee clinical development PV through the PV Clinical Development Lead.

Key Responsibilities:

Make and articulate benefit-risk determinations for commercial products and approve those for clinical programs.
Adjudicate signals, supervise medical review, and serve as the final safety decision-maker.
Own regulatory compliance, aggregate safety reports, and interactions with health authorities including inspections.

Building the Team:

Design and implement the pharmacovigilance operating model, including recruitment, training, and team development.
Establish and maintain the quality system, safety database, and AI governance framework.
Work cross-functionally with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and Commercial to ensure comprehensive safety oversight.

Praxis Precision Medicines

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results, aiming to achieve the impossible together.

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