Pharmacovigilance Officer (Remote)

About the Role

Our client is seeking a vigilant and detail-oriented Pharmacovigilance Officer to join their drug safety team, operating remotely within South Africa. This crucial role involves monitoring the safety of pharmaceutical products after they have been authorized and distributed. You will be responsible for collecting, detecting, assessing, monitoring, and preventing adverse effects or any other drug-related problems. Your work directly contributes to patient safety and regulatory compliance. This is an ideal opportunity for a dedicated professional in drug safety to work autonomously within a supportive global pharmacovigilance network, ensuring the highest standards of patient well-being.

Key Responsibilities

• Collect, process, and report adverse event (AE) data in compliance with global regulatory requirements and company procedures.
• Perform case assessment, including seriousness, expectedness, and causality evaluations.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and risk management plans.
• Maintain the safety database and ensure accurate and timely data entry.
• Liaise with internal departments (e.g., Regulatory Affairs, Clinical Operations) and external stakeholders (e.g., healthcare professionals, regulatory authorities) on safety matters.
• Participate in signal detection activities and safety data review meetings.
• Contribute to the development and updating of pharmacovigilance SOPs and training materials.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, or a related healthcare/life science field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., ICH E2B, E2C).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical and critical thinking skills for case assessment and signal detection.
• Excellent written and verbal communication skills, with high attention to detail.

Benefits

• Competitive remote salary and comprehensive benefits package.
• Company-provided equipment and a stipend for home office setup.
• Opportunities for professional development in drug safety and regulatory compliance.
• Flexible working hours and the ability to manage your own schedule.
• Be part of a critical function ensuring patient safety worldwide.