Safety Writer III
Core
Plan, coordinate, and deliver complex safety writing deliverables (e.g., DSURs, RMPs, regulatory authority responses) for clinical trials and marketed products in a pharmacovigilance environment.
Role type
Senior Safety Writer / Pharmacovigilance Project Lead
Builds
Regulatory safety reports and risk management plans for pharmaceutical clients
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical-scientific writing, ICH aggregate safety reporting, risk management planning, project management, data review, quality review, regulatory compliance, budget forecasting, mentoring
Preferred skills
None stated
Technologies
Microsoft Office (Outlook, Word, Excel), PPD systems, client systems
Responsibilities
Author and review safety reports of varying complexity; manage project timelines, communications, and budgets; mentor less experienced staff; ensure compliance with regulations and company policies; lead kick-off meetings and client interactions.
Seniority
Senior, hands-on IC with mentorship responsibilities
