Pharmacovigilance Scientist II — Aggregate Reports Lead

Staffwise; Cape Town; On-site; ZAR 900,000 - 1,200,000; Full time

Job summary

IQVIA is seeking a Pharmacovigilance Scientist 2 to lead signal detection and literature surveillance, and to author aggregate reports (PBRERs/PSURs/DSURs) with responses to regulatory inquiries. The role requires delivering high-quality safety deliverables across products and maintaining KPI-driven timelines.

You will coordinate across cross-functional teams, ensure documentation quality, participate in audits, and maintain in-depth molecule knowledge within the team.

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, evaluating events of special interests as well as aggregate data review
• Author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs and ACOs
• Author responses to regulatory agency/ PRAC inquiries, as required
• Can serve as principal owner for the molecule and ensure delivery in compliance with KPI; set-up and update signaling strategies; author and/or QC review signal management deliverables
• Oversee molecule deliverables, liaise with portfolio clinical science scientists and cross-functional stakeholders
• Distribute molecule work within team and coordinate across molecules/disease areas
• End-to-end molecule work oversight (detection to inclusion in aggregate reports)
• Ensure in-depth knowledge of the molecule and disease area within the team
• Oversee quality of deliverables to the customer; participate in SD/Lit meetings
• Participate in audits/inspections and ensure SOP compliance
• Share lessons learned with teams to cascade customer information

Skills

Pharmacovigilance

Communication

Teamwork

English Fluency

Education

Life science degree

Job description

IQVIA is seeking a Pharmacovigilance Scientist 2 to lead signal detection and literature surveillance, and to author aggregate reports (PBRERs/PSURs/DSURs) with responses to regulatory inquiries. The role requires delivering high-quality safety deliverables across products and maintaining KPI-driven timelines.

You will coordinate across cross-functional teams, ensure documentation quality, participate in audits, and maintain in-depth molecule knowledge within the team.