Client Dedicated Safety Writer II
Core
Plan, coordinate, and deliver safety writing services for clinical trial and marketed product projects in a regulated pharmacovigilance environment.
Role type
Senior IC safety writer and project manager
Builds
Safety reports (PA[D]ERs, DSURs, PSURs/PBRERs, dRMPs) and related regulatory deliverables
Domain
Life sciences / Pharmacovigilance
Required skills
Medical-scientific writing, data review, project management, regulatory reporting (ICH/US), critical thinking, budget forecasting, system navigation
Preferred skills
None stated
Technologies
Microsoft Office (Outlook, Word, Excel), client systems
Responsibilities
Conduct data review, authoring, and quality review of safety deliverables; manage project timelines and communications; lead kick-off meetings and client interactions; review regulatory publications; ensure compliance with policies and regulations.
Seniority
Senior, hands-on IC