Global PV Lead: Safety Signals & Reports

IQVIA; Bloemfontein; On-site; ZAR 1,400,000 - 2,000,000; Full time

Job summary

IQVIA is seeking a stand-alone global lead for Safety Aggregate Report and Analytics (SARA) Center deliverables. You will manage safety aggregate reports, literature surveillance, and signal management across projects, while ensuring compliance with SOPs and GDP.

Leadership includes mentoring staff and coordinating with client teams. You will collaborate with cross-functional groups, drive process improvements, and support regulatory inquiries as required.

Qualifications

• Life science degree or related qualification or experience in pharmacovigilance.
• 5–10 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.
• Strong organizational and time management skills. Proven ability to meet strict deadlines.
• English – fluent (spoken, written)

Responsibilities

• 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) and responses to regulatory inquiries.
• Act as literature lead and back-up reviewer for literature safety surveillance of products.
• Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects.
• Oversee/c conduct signal detection activities, documentation, KPIs and audits.
• Provide training to SARA staff for qualification on SARA deliverables.
• Mentor and coach project team staff; interface with clients and multiple functional groups.
• Participate in audits and ensure SOP/GDP compliance and final deliverable quality.

Skills

Pharmacovigilance experience

Communication skills

Organizational skills

Time management

English fluent

Education

Life science degree or related qualification

Job description

IQVIA is seeking a stand-alone global lead for Safety Aggregate Report and Analytics (SARA) Center deliverables. You will manage safety aggregate reports, literature surveillance, and signal management across projects, while ensuring compliance with SOPs and GDP.

Leadership includes mentoring staff and coordinating with client teams. You will collaborate with cross-functional groups, drive process improvements, and support regulatory inquiries as required.