Associate Manager, Drug Safety Public Health

Associate Manager, Drug Safety Public Health
  • $50 - $115 per Hour
  • Temporary
  • Foster City CA, US Foster City SAN MATEO US 94404
Job Ref: JO000117700
Sector: Clinical
Sub-sector: Project Management
Date Added: 18 May 2021

Associate Manager, Drug Safety Public Health
• Scientific/Medical Writing ability: author large complex documents summarizing aggregate data (for example PSUR/PBRERs, DSURs) and detailed Safety Reviews
• Project Management ability: manage complex timelines to achieve on time completion with cross-functional collaboration and delivery of key documents including Reference Safety Information, Marketing Application components and signal detection deliverables
• Scientific Analytic ability: determine methodology and prepare responses to requests for information from Health Authorities; communicate analysis needs to Biometrics, author Safety Reviews, manage timeline and authoring responses
• Signal Detection and Management: review of individual case safety reports to identify potential signals; participate in and track signal detection work ups according to procedural documents
• Knowledge of GVP and ICH regulations and applicable company procedural documents: assuring compliance with regulations and procedures and adequate documentation of compliance; responding to audits and inspections
• 5+ years direct pharmacovigilance experience in writing PSURs, DSURs and Safety Reviews required; 7+ years preferable
• Biology, Medical, or Pharmacy-related degree preferable
• Experience using project management software desirable

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

19/07/2022 12:00:00
USD 50.00 115.00 Hour
Contact Consultant:
Angela Leick

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