Pharmacovigilance Specialist

About the Role

Our client seeks a vigilant and detail-oriented Pharmacovigilance Specialist to join their team in Nelspruit . This role is crucial for monitoring the safety of pharmaceutical products post-market, ensuring that potential adverse events are identified, assessed, and managed effectively to protect public health. You will work with a dedicated safety team to collect, process, and report safety information according to global regulatory standards.

This position offers a vital role in ensuring drug safety and compliance within the pharmaceutical industry.

• Collect, assess, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Process safety data in the pharmacovigilance database in accordance with company procedures and regulatory requirements.
• Prepare and submit regulatory safety reports (e.g., Periodic Safety Update Reports - PSURs, Development Safety Update Reports - DSURs) to health authorities.
• Liaise with internal departments and external stakeholders on safety-related matters.
• Conduct literature reviews for potential safety signals and emerging risks.
• Support audits and regulatory inspections related to pharmacovigilance activities.

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance , drug safety, or a related regulatory compliance role.
• Knowledge of global pharmacovigilance regulations and reporting requirements (e.g., FDA, EMA, SAHPRA).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical, written, and verbal communication skills.
• Ability to manage multiple tasks, prioritize effectively, and meet deadlines.

• Competitive annual salary and potential for performance bonuses.
• Comprehensive health, dental, and vision benefits.
• Support for continuous professional development in drug safety.
• A collaborative and supportive team environment focused on patient safety.
• Flexible working arrangements, including hybrid work options.
• Paid time off and company holidays.