Drug Safety Specialist

About the Role

Our client is seeking a vigilant and experienced Drug Safety Specialist to join their remote team, supporting operations from Richards Bay . This role is integral to ensuring patient safety by monitoring, collecting, and evaluating adverse event reports associated with pharmaceutical products. You will be responsible for maintaining accurate safety databases and ensuring compliance with global regulatory requirements for pharmacovigilance. This is a key position that allows you to contribute to patient well-being from anywhere, while being part of a dedicated global team focused on maintaining the highest standards of drug safety and risk management.

• Collect, process, and evaluate adverse event (AE) reports from various sources, ensuring accuracy and completeness.
• Enter safety data into the company's pharmacovigilance database in compliance with regulatory timelines.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Prepare aggregate safety reports, such as Periodic Safety Update Reports (PSURs), for regulatory submission.
• Liaise with healthcare professionals, regulatory authorities, and internal departments on drug safety matters.
• Contribute to the development and maintenance of safety monitoring plans and risk management strategies.

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Strong understanding of global regulatory requirements for drug safety reporting (e.g., FDA, EMA, SAHPRA).
• Experience with pharmacovigilance databases (e.g., Argus, ArisG) and safety reporting systems.
• Excellent analytical skills and meticulous attention to detail in data management.
• Proficiency in written and verbal communication, with the ability to articulate complex safety information clearly.

• Competitive annual salary and potential for remote work stipends.
• Comprehensive health and wellness benefits package.
• Opportunities for specialized training in pharmacovigilance and regulatory affairs.
• Flexible working hours and the ability to work remotely.
• Contribute to the critical mission of patient safety in the pharmaceutical sector.
• A supportive and collaborative remote work culture.