Director, Drug Safety & Pharmacovigilance Scientist
Core
Strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management across clinical development programs for neuromuscular diseases.
Role type
Director, Drug Safety & Pharmacovigilance Scientist
Builds
Safety strategies, regulatory submissions, and risk mitigation plans for investigational therapies.
Domain
Biotechnology / Pharmacovigilance / Neuromuscular Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Safety surveillance, signal detection, benefit-risk assessment, risk management, regulatory compliance (FDA/EMA/ICH/GVP), ICSR review, aggregate safety reporting (DSUR/PSUR), vendor oversight, scientific writing, cross-functional leadership
Preferred skills
Rare disease experience, neuromuscular disease expertise, advanced degree (MD/PharmD/PhD)
Technologies
MedDRA, safety databases, ICSR workflows
Responsibilities
Lead safety surveillance and signal detection activities; Author aggregate safety reports and regulatory responses; Develop safety monitoring strategies and risk mitigation plans; Partner with cross-functional teams to integrate safety into program strategy; Maintain inspection-ready documentation and enhance PV processes.
Seniority
Director, strategic leadership & cross-functional influence
