Pharmacovigilance Scientist 2 (safety Aggregate Report Specialist 2)

IQVIA

Multiple Locations
Signal detection and literature lead
Author aggregate reports
Author responses to regulatory agencies
Act as signal detection and literature lead, or back-up lead to contribute to the conduct of ongoing literature safety surveillance for marketed and investigational products, evaluating events of special interests as well as aggregate data review

Job Summary

  • Act as signal detection and literature lead, or back-up lead to contribute to the conduct of ongoing literature safety surveillance for marketed and investigational products, evaluating events of special interests as well as aggregate data review.
  • Author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs and ACOs.
  • Responsible for full documentation and tracking of signals, ensuring the completion of molecule deliverables on time and liaise with portfolio clinical science scientists, service provider process leads and cross-functional stakeholders.

Matching Summary

Act as signal detection and literature lead, or back-up lead to contribute to the conduct of ongoing literature safety surveillance for marketed and investigational products, evaluating events of special interests as well as aggregate data review.

Skills & Requirements

Must-have

  • signal detection and literature lead
  • author aggregate reports
  • author responses to regulatory agencies
  • product signaling strategies
  • signal management deliverables
  • signal detection activities
  • molecule deliverables oversight

Nice-to-have

  • in-depth knowledge of disease area
  • internal and external audits participation
  • lessons learned with working teams

Key Requirements

  • 4-6 years of relevant experience
  • Life science graduate/post-graduate
  • Excellent communication skills
  • Fluent English

Work Rights

Not specified

Tailored Resume

Cover Letter