Safety Aggregate Report Specialist

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Safety aggregate report and analytics (sara)
Literature surveillance
Signal management activities
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA)

Job Summary

  • Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
  • Conduct/Lead ongoing literature safety surveillance for marketed and investigational products and act as Signal Management Lead on post-marketing and clinical trial projects.
  • Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.

Matching Summary

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).

Skills & Requirements

Must-have

  • Safety Aggregate Report and Analytics (SARA)
  • literature surveillance
  • signal management activities
  • benefit risk management documents
  • PBRERs/PSUR, DSURs, PADERs
  • regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries

Nice-to-have

  • client interface
  • internal audits and inspections
  • mentorship and training
  • technology / innovation activities

Key Requirements

  • Bachelor's Degree in Scientific or Healthcare discipline
  • 2 - 3 years relevant work experience
  • In depth knowledge of regulatory requirements (GCP, GVP, ICH)
  • Proven ability to meet strict deadlines

Work Rights

Not specified

Tailored Resume

Cover Letter