Senior Manager, Safety Scientist
Core
Lead global patient safety risk evaluation and management across the product lifecycle, ensuring compliance with GxP and global regulations.
Role type
Senior Manager, Safety Scientist (Pharmacovigilance)
Builds
Regulatory safety submissions, risk management plans, and safety strategies for assigned therapeutic assets.
Domain
Life Sciences / Pharmacovigilance / Rare Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Safety data analysis, regulatory document authoring, aggregate safety reporting, signal analysis, risk management planning, project management, cross-functional stakeholder engagement, global regulatory knowledge, scientific writing, team leadership.
Preferred skills
Advanced degree (PharmD, PhD, Nurse Practitioner), clinical development experience, MedDRA coding expertise, data visualization (Power BI, Spotfire), safety database management.
Technologies
eCTD, MedDRA, Power BI, Spotfire
Responsibilities
Review and analyze safety data for designated therapeutic areas; author and review clinical safety documents (protocols, IB, CSR); prepare aggregate safety reports (PSUR, PBRER); oversee safety strategies and surveillance teams; lead signal analysis and communication; manage health authority queries; develop risk management plans; train junior safety scientists; support regulatory filings and label updates.
Seniority
Senior Manager, hands-on IC with leadership responsibilities
