Senior Pharmacovigilance Scientist - Signal Detection & Reports

Nacba; Cape Town; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Nacba seeks a Pharmacovigilance Scientist 2 to lead signal detection and safety data aggregation across multiple markets. You will manage literature surveillance and author critical safety documents for marketed and investigational products, ensuring timely, compliant outputs.

Responsibilities include creating PBRERs/PSURs/DSURs, replying to regulatory inquiries, and coordinating cross-functional teams to deliver molecule deliverables with high quality and on schedule.

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.

Responsibilities

• Act as signal detection and literature lead, or back-up lead to contribute to surveillance for marketed/investigational products and review aggregate data.
• Author and finalize aggregate reports, including PBRERs/PSUR, DSURs and ACOs.
• Author responses to regulatory agency/PRAC inquiries, as required.
• Lead/supervise molecule deliverables, set-up signaling strategies, and author/review signal management deliverables.
• Ensure completion of molecule deliverables on time and coordinate with cross-functional stakeholders.
• Distribute molecule work within the team and coordinate across molecules/disease areas when workload peaks.
• Oversee end-to-end molecule work tracking from detection to inclusion in aggregate reports.
• Maintain in-depth knowledge of the molecule and disease area within the service provider team.
• Ensure quality of molecule deliverables, contribute to DSR conclusions, and participate in SD/Lit meetings.
• Resolve issues on molecule deliverables in collaboration with process leads.
• Participate in internal and external audits and inspections, as required.
• Read, acknowledge and adhere to IQVIA SOPs and customer SOPs; complete required training timely.
• Conduct regular lessons learned with teams to cascade information from the customer.

Skills

Communication skills

Team working

Education

Life science degree

Job description

Nacba seeks a Pharmacovigilance Scientist 2 to lead signal detection and safety data aggregation across multiple markets. You will manage literature surveillance and author critical safety documents for marketed and investigational products, ensuring timely, compliant outputs.

Responsibilities include creating PBRERs/PSURs/DSURs, replying to regulatory inquiries, and coordinating cross-functional teams to deliver molecule deliverables with high quality and on schedule.