Remote Pharmacovigilance Specialist

Our client is seeking a proactive and experienced Remote Pharmacovigilance Specialist to join their dedicated safety team, supporting pharmaceutical operations that may originate from Paarl, Western Cape. This is a fully remote position, allowing you to contribute to patient safety from anywhere within South Africa. You will play a crucial role in monitoring, collecting, and evaluating adverse event reports, ensuring compliance with global pharmacovigilance regulations and contributing to the safe use of pharmaceutical products.

Your vigilance is essential in protecting public health.

• Collect, assess, and document adverse event reports from various sources, ensuring completeness and accuracy.
• Perform case processing, including data entry into safety databases, coding using MedDRA, and determining seriousness and causality.
• Prepare and submit regulatory safety reports (e.g., Periodic Safety Update Reports - PSURs, Development Safety Update Reports - DSURs) as required.
• Conduct literature searches for potential safety signals and emerging risks.
• Liaise with healthcare professionals, regulatory authorities, and internal stakeholders on safety-related matters.
• Contribute to the development and maintenance of pharmacovigilance procedures and training materials.

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., ICH E2B, GVP).
• Experience with safety database systems and MedDRA coding.
• Strong analytical skills and attention to detail in reviewing safety data.
• Excellent written and verbal communication skills for effective reporting and liaison.

• Competitive annual salary and performance-related bonuses.
• Comprehensive medical aid and retirement fund.
• Flexible remote working hours and location.
• Paid professional development and training opportunities.
• A supportive team environment focused on maintaining drug safety and public health.