Pharmacovigilance Scientist 2 (safety Aggregate Report Specialist 2)

IQVIA UK

United Kingdom
Signal detection and literature lead
Aggregate reports authoring
Regulatory agency inquiries
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.
  • Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks, as approved by the customer’s Safety Strategy Lead.

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
  • aggregate reports authoring
  • regulatory agency inquiries
  • signaling strategies setup
  • signal management deliverables
  • proactive risk identification

Nice-to-have

  • in-depth molecule knowledge
  • collaboration with stakeholders
  • internal and external audits

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter