Remote Pharmacovigilance Specialist - Global Drug Safety

Placements24; Stellenbosch; Hybrid; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Remote work benefits

Health insurance

Paid time off

Professional development

Work from home

Job summary

Placements24 seeks a Pharmacovigilance Specialist to join a fully remote team, supporting global drug safety programs. You will monitor, evaluate, and prevent adverse effects while ensuring compliance with FDA, EMA, SAHPRA and other global guidelines.

Responsibilities include collecting AE reports, causality assessments, timely regulatory submissions, PSURs, and maintaining safety databases. The role offers remote, flexible hours and the chance to contribute to patient safety from Stellenbosch

Qualifications

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related life science field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety monitoring.
• Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, SAHPRA).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical skills and attention to detail.
• Excellent written and verbal communication skills, with the ability to work effectively in a remote , collaborative environment.

Responsibilities

• Collect, process, and evaluate adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Perform case assessment, including causality assessment and seriousness determination.
• Ensure timely reporting of adverse events to regulatory authorities and internal stakeholders.
• Contribute to the preparation of aggregate safety reports, such as Periodic Safety Update Reports (PSURs).
• Participate in safety surveillance activities, signal detection, and risk management planning.
• Maintain and update safety databases, ensuring data accuracy and integrity for global compliance.

Skills

Analytical skills

Attention to detail

Communication skills

Remote collaboration

Education

Life science degree

Job description

Placements24 seeks a Pharmacovigilance Specialist to join a fully remote team, supporting global drug safety programs. You will monitor, evaluate, and prevent adverse effects while ensuring compliance with FDA, EMA, SAHPRA and other global guidelines.

Responsibilities include collecting AE reports, causality assessments, timely regulatory submissions, PSURs, and maintaining safety databases. The role offers remote, flexible hours and the chance to contribute to patient safety from Stellenbosch