Pharmacovigilance Signals & Aggregate Reports Lead

Roche

Cape Town

On-site

ZAR 600,000 - 900,000

Full time

5 days ago

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Job summary

IQVIA currently seeks a Pharmacovigilance Scientist 2 to lead signal detection and literature surveillance for marketed and investigational products. The role includes authoring PBRERs/PSURs/DSURs, responding to regulatory inquiries, and coordinating molecule deliverables within a cross-functional team.

Ideal candidates have 4–6 years in pharmacovigilance, strong communication skills, and fluency in English.

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 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.
Lead/conduct ongoing signal detection activities and signal evaluation analyses.
Ensure timely completion of molecule deliverables and coordinate with cross-functional stakeholders.
Oversee molecule work across team members and disease areas as workload peaks.