Global PV Lead for Aggregate Reporting & Signal Management

IQVIA; Centurion; Vor Ort; ZAR 900.000 - 1.500.000; Vollzeit

Zusammenfassung

IQVIA is seeking a stand-alone global functional lead for Safety Aggregate Report and Analytics (SARA) Center deliverables, applying pharmacovigilance expertise to safety reports, literature surveillance, signal management and risk assessment documents, collaborating with Lifecycle Safety teams and client projects.

You will author and finalize aggregate reports (PBRERs/PSURs, DSURs, PADERs, etc.), guide literature surveillance, and lead safety signaling activities, mentoring staff and ensuring

Qualifikationen

• Life science graduate/post‑graduate, pharmacy, nursing, or other healthcare qualification or experience in pharmacovigilance.
• 5–10 years of relevant pharmacovigilance experience including hands-on drug safety, aggregate reports, and signal management.
• Excellent written and verbal communication skills.
• Strong organizational and time‑management skills with proven ability to meet deadlines.
• Ability to manage competing priorities and adapt to changing demands.
• English – fluent (spoken and written).

Aufgaben

• Serve as a stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects.
• Lead, author and finalize aggregate reports (PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings).
• Author responses to regulatory inquiries to support labeling and safety documents.
• Act as literature lead for literature safety surveillance of marketed and investigational products.
• Lead safety signaling activities, set up and oversee safety management teams and data mining methodologies.
• Oversee signal detection activities, perform validation and evaluation analyses, and maintain documentation and metrics for audits.

Ausbildung

Life science degree

Jobbeschreibung

IQVIA is seeking a stand-alone global functional lead for Safety Aggregate Report and Analytics (SARA) Center deliverables, applying pharmacovigilance expertise to safety reports, literature surveillance, signal management and risk assessment documents, collaborating with Lifecycle Safety teams and client projects.

You will author and finalize aggregate reports (PBRERs/PSURs, DSURs, PADERs, etc.), guide literature surveillance, and lead safety signaling activities, mentoring staff and ensuring