Pharmacovigilance Specialist - Remote

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

About the Role

Our client is seeking a vigilant and experienced Pharmacovigilance Specialist to join their remote team, supporting global drug safety initiatives. This crucial role involves the monitoring, detection, assessment, and prevention of adverse effects or any other drug-related problems. You will be responsible for ensuring compliance with all relevant pharmacovigilance regulations and guidelines, contributing to the safety profile of our client's pharmaceutical products worldwide. This fully remote position allows you to leverage your expertise from anywhere, making a significant impact on patient safety and public health through diligent data analysis and reporting.

Key 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.

Requirements

• 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.

Benefits

• Competitive annual salary and remote work benefits.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and flexible working hours.
• Opportunities for professional development in drug safety and regulatory compliance.
• The ability to work from home while contributing to global patient safety from anywhere, including Stellenbosch .