Senior Pharmacovigilance Specialist | Drug Safety Lead

Pfizer South Africa; Middelburg; On-site; EUR 19,000 - 27,000; Full time

Benefits offered by this job

Medical and dental coverage

Retirement plan

Generous leave

Performance-based bonuses

Wellness programs

International assignments

Job summary

Pfizer South Africa is seeking a Pharmacovigilance Specialist to monitor and assess safety profiles of marketed products within South Africa. You will work with clinical research, regulatory and medical affairs to ensure regulatory compliance and robust safety data capture.

The role requires 5+ years in drug safety, a Bachelor’s in Pharmacy/Life Sciences, and a strong knowledge of GVP. Master’s in PV preferable with experience using Argus/ArisG; offering growth and regional exposure.

Qualifications

• Minimum 5 years in drug safety or pharmacovigilance.
• Bachelor’s degree in Pharmacy, Life Sciences, or related field.
• A Master’s degree or PV certification is highly desirable.

Responsibilities

• Collect, review, and evaluate adverse event reports.
• Submit safety reports to SAHPRA and global regulators.
• Perform signal detection and risk assessments; develop mitigations.
• Collaborate with clinical, regulatory, and medical teams.
• Maintain safety databases compliant with GVP.
• Support labeling, packaging, and promotional safety reviews.
• Prepare PSURs and DSURs.
• Participate in audits and inspections.

Skills

Pharmacovigilance

GVP

SAHPRA

Argus

ArisG

Data analysis

Education

Bachelor’s degree in Pharmacy/Life Sciences

Master’s degree preferred

Tools

Argus

ArisG

Job description

Pfizer South Africa is seeking a Pharmacovigilance Specialist to monitor and assess safety profiles of marketed products within South Africa. You will work with clinical research, regulatory and medical affairs to ensure regulatory compliance and robust safety data capture.

The role requires 5+ years in drug safety, a Bachelor’s in Pharmacy/Life Sciences, and a strong knowledge of GVP. Master’s in PV preferable with experience using Argus/ArisG; offering growth and regional exposure.