Pharmacovigilance Officer - Drug Safety

Our client is seeking a diligent and safety-focused Pharmacovigilance Officer to join their Drug Safety department in Nelspruit. This crucial role involves the monitoring, detection, assessment, and prevention of adverse effects of pharmaceutical products. You will be responsible for managing the entire lifecycle of adverse event reporting, from case processing to regulatory submissions, ensuring compliance with all relevant safety regulations. This position offers a vital contribution to patient safety and public health by safeguarding the integrity of marketed pharmaceutical products.

We are looking for a dedicated professional committed to upholding the highest standards of drug safety surveillance within the pharmaceutical industry.

• Process and manage adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of adverse events to regulatory authorities (e.g., SAHPRA).
• Conduct case assessments, including seriousness, causality, and expectedness determination.
• Contribute to the preparation of aggregate safety reports, such as Periodic Safety Update Reports (PSURs).
• Maintain the pharmacovigilance database and ensure data quality and integrity.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory) and external stakeholders on safety matters.

• Degree in Pharmacy, Nursing, Medicine, or a related life science field.
• Minimum of 3 years of experience in Pharmacovigilance or Drug Safety roles within the pharmaceutical sector.
• Thorough understanding of drug safety principles and regulatory requirements for adverse event reporting.
• Experience with safety databases (e.g., Argus, Arisg) and case processing.
• Excellent attention to detail, organizational skills, and ability to manage urgent tasks.
• Strong communication and interpersonal skills for effective collaboration within the Nelspruit office.

• Competitive annual salary and potential for yearly bonuses.
• Comprehensive health, wellness, and retirement benefits package.
• Generous annual leave and paid time off.
• Opportunities for professional development and advanced training in pharmacovigilance.
• A stable and supportive work environment within a respected pharmaceutical organization in Mpumalanga.