Praxis Precision Medicines, Inc. · 2 hours ago
Senior Director, Safety/Pharmacovigilance
United States
Full-time
Remote
Director/Executive
$278K/yr - $301K/yr
8+ years expPraxis Precision Medicines, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. They are seeking a Senior Director of Safety/Pharmacovigilance to oversee drug safety activities and lead global pharmacovigilance operations, ensuring compliance and effective risk management.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
Responsibilities
Providing oversight and daily management of all activities pertaining to drug safety within the Praxis pharmacovigilance (PV) department globally
Includes: leadership and oversight of global PV operations, personnel and strategic resource planning; oversight of developing compliant PV procedures and training modules; oversight of timely safety reporting to regulatory authorities and external business partners; implementation of strategies to manage safety risks; ensure PV department maintains inspection readiness, including representing the company during audits and pharmacovigilance inspections; monitor key performance indicators for PV vendors; collaborate cross-functionally to ensure timely authoring of key safety deliverables including periodic safety updates and regulatory query responses; and lead PV/safety aspects of NDA/MAA preparation, including authoring of integrated safety summary and drafting labeling
Leads capabilities enhancement within PV, including implementation of safety database and data visualization tools for signal detection
Oversight of relationships with external business partners, including overseeing the alliance, associated requests, and PV agreements, ensuring mechanisms are in place for governance of partnerships
Qualification
Required
MD, DO, PharmD, PhD, or foreign equivalent in Medicine, Pharmacy, or related clinical field, such as Epidemiology or Public Health
8 years of experience in a Pharmacovigilance role within the Pharmaceutical / Biotechnology industry
8 years of experience ensuring PV procedures remain compliant with regulatory guidance by maintaining knowledge of good Pharmacovigilance practices and the evolving regulatory landscape
8 years of experience in pharmacovigilance case processing, including case management, and individual and aggregate case reporting
8 years leading PV operations, including oversight of third-party vendors
4 years of experience implementing post marketing and clinical trial safety surveillance and reporting requirements
1-year minimum experience implementing post marketing and clinical trial safety surveillance and reporting requirements in decentralized trials
4 years of experience interacting externally and internally to support the scientific and business strategy
3 years of experience managing PV for small molecules and antisense oligonucleotides, for both rare and prevalent diseases
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-13
Company data provided by crunchbase