Global PV Lead: Aggregate Reporting & Signal Management

IQVIA

Bellville (TX)

On-site

USD 55,000 - 79,000

Full time

4 days ago
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Job summary

IQVIA seeks an experienced Safety Aggregate Report and Analytics (SARA) Center lead to drive global aggregate reports, signal management and literature surveillance. You will guide lifecycle safety processes, mentor teams, and ensure compliance with SOPs and regulatory expectations.

The role demands strong pharmacovigilance expertise, excellent communication, cross-functional leadership, and ability to deliver high-quality deliverables across projects and audits.

Qualifications

  • 5-10 years of pharmacovigilance experience including drug safety and aggregate reports.
  • Excellent communication (written and verbal) skills.
  • Fluency in English (spoken and written).

Responsibilities

  • Serve as stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects.
  • Lead, author and finalize reports (PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, etc.).
  • Author responses to regulatory inquiries as required.
  • Mentor and coach SARA staff; provide training on deliverables.
  • Oversee signaling strategies and data mining methodologies across projects.
  • Ensure project documentation, compliance, and KPI reporting for audits.

Skills

Pharmacovigilance
Safety reporting
PBRER/PSUR
Regulatory liaison
Communication
Team leadership
English fluency

Education

Life science degree

Job description

IQVIA seeks an experienced Safety Aggregate Report and Analytics (SARA) Center lead to drive global aggregate reports, signal management and literature surveillance. You will guide lifecycle safety processes, mentor teams, and ensure compliance with SOPs and regulatory expectations.

The role demands strong pharmacovigilance expertise, excellent communication, cross-functional leadership, and ability to deliver high-quality deliverables across projects and audits.

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