EMEA Pharmacovigilance Signal Lead Scientist II/III

Iqvia; Viseu; On-site; EUR 70,000 - 90,000; Full time

Job summary

IQVIA is seeking a signal detection and literature lead within our Pharmacovigilance team in Portugal. You will oversee end-to-end signal management, author aggregate reports, and respond to regulatory inquiries, ensuring compliance with KPI and QA standards.

You will lead molecule-specific work streams, set up signaling strategies, coordinate with cross-functional teams, and drive timely delivery of safety deliverables across PBRER/PSUR/DSUR programs while maintaining high data integrity.

Qualifications

• Life science graduate/post-graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• 4-6 years of relevant experience in Pharmacovigilance including hands-on experience of drug safety, aggregate reports, signal detection/signal management preferred
• Excellent communication (written and verbal) skills

Responsibilities

• Act as signal detection and literature lead, or back-up lead to contribute to ongoing literature safety surveillance for marketed and investigational products
• Author and finalize aggregate reports, including PBRERs/PSUR, DSURs and ACOs
• Author responses to regulatory agency inquiries as required
• Set-up and update signaling strategies and authoring/review of signal management deliverables
• Lead ongoing signal detection activities, conduct signal validation/evaluation analyses
• Ensure documentation and tracking of signals across the life-cycle
• Coordinate with portfolio clinical science scientists and cross-functional stakeholders
• End-to-end molecule work oversight and responsibility for deliverables
• Participate in audits and ensure SOP adherence

Skills

Pharmacovigilance

Signal detection

Aggregate reports

Leadership

Education

Life science degree

Post-graduate pharmacovigilance

Job description

IQVIA is seeking a signal detection and literature lead within our Pharmacovigilance team in Portugal. You will oversee end-to-end signal management, author aggregate reports, and respond to regulatory inquiries, ensuring compliance with KPI and QA standards.

You will lead molecule-specific work streams, set up signaling strategies, coordinate with cross-functional teams, and drive timely delivery of safety deliverables across PBRER/PSUR/DSUR programs while maintaining high data integrity.