Pharmacovigilance Signal & Aggregate Reports Lead

Peri Gmbh Formwork Scaffolding Engineering; Cape Town; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA is seeking a Pharmacovigilance Scientist 2 to lead signal detection and literature surveillance for marketed and investigational products in a global safety environment. You will author PSURs/DSURs and respond to agency inquiries as required, with ownership of molecule deliverables and signaling strategies.

You will coordinate with cross-functional teams, ensure quality deliverables, and contribute to audits and inspections ensuring regulatory compliance and data integrity across safety

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.
• Team working.
• English - fluent (spoken, written).

Responsibilities

• Act as signal detection and literature lead, or back-up lead to contribute to safety surveillance for marketed and investigational products, evaluating events of special interests and performing aggregate data review.
• Author and finalize aggregate reports, including PSURs/DSURs and ACOs.
• Author responses to regulatory agency inquiries as required.
• Set up and update signaling strategies; author and QC various signal management deliverables and oversee end-to-end signal detection activities.
• Ensure timely completion of molecule deliverables and coordinate with cross-functional stakeholders.
• Lead distribution of workload within the molecule team and oversee global signal tracking.

Skills

Pharmacovigilance

Communication

Teamwork

Literature surveillance

English fluency

Education

Life science degree

Job description

IQVIA is seeking a Pharmacovigilance Scientist 2 to lead signal detection and literature surveillance for marketed and investigational products in a global safety environment. You will author PSURs/DSURs and respond to agency inquiries as required, with ownership of molecule deliverables and signaling strategies.

You will coordinate with cross-functional teams, ensure quality deliverables, and contribute to audits and inspections ensuring regulatory compliance and data integrity across safety