Clinical Safety Manager - Pharmacovigilance / Drug Safety
Core
Manage clinical safety activities, case management, and aggregate reporting for multiple large programs in the pharmacovigilance process.
Role type
Senior Clinical Safety Manager (Pharmacovigilance)
Builds
Safety management plans, clinical study documents, regulatory submissions, and aggregate safety reports for biotech, pharma, and medical device clients.
Domain
Clinical Research / Pharmacovigilance / Drug Safety
Deliverable
client delivery
Required skills
Clinical safety project management, line management experience, SOP and work instruction writing, PSMF generation and maintenance, CCDS/RMP/SmPC writing, global clinical safety regulatory knowledge
Preferred skills
Business development presentation skills, audit participation, cost estimation
Technologies
None stated
Responsibilities
Manage clinical safety activities and multiple large programs; Oversee clinical safety case management and aggregate reporting; Provide safety review of clinical study documents; Create safety management plans; Attend business development activities; Write departmental SOPs and Work Instructions
Seniority
Senior, hands-on IC with line management experience