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Our client is seeking an experienced Senior Pharmacovigilance Specialist to join their global safety team, supporting operations traditionally based in Nelspruit .
Key Responsibilities • Collect, assess, and report adverse event data according to global regulatory requirements and company procedures. • Conduct signal detection and risk assessment activities for assigned products. • Prepare and submit periodic safety update reports (PSURs) and other regulatory safety documents. • Contribute to the development and maintenance of pharmacovigilance SOPs and training materials. • Liaise with external stakeholders, including regulatory authorities, healthcare professionals, and internal teams. • Participate in cross-functional safety team meetings and provide safety-related expertise.
Benefits • Highly competitive annual salary and performance bonus. • Comprehensive medical, dental, and vision insurance. • Retirement savings plan and life insurance. • Generous professional development allowance for courses and certifications. • A fully remote position offering unparalleled flexibility and work-life integration.
This pivotal role involves monitoring the safety of pharmaceutical products post-market, ensuring compliance with global safety regulations, and managing adverse event reporting. You will work from a remote location, playing a crucial part in safeguarding public health by maintaining the safety profile of our client's medicines.
This is an excellent opportunity for a dedicated professional to contribute significantly to patient safety from a flexible work environment.
Requirements • Bachelor's degree in Pharmacy, Medicine, Nursing, or a related healthcare/life science field. • Minimum of 5 years of experience in Pharmacovigilance or drug safety. • Thorough knowledge of global pharmacovigilance regulations (e.g., ICH guidelines, FDA, EMA, SAHPRA). • Experience with safety databases (e.g., Argus, ArisG) and adverse event reporting systems. • Strong analytical skills and the ability to interpret complex safety data. • Excellent written and verbal communication skills, essential for effective remote collaboration and reporting.
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