Pharmacovigilance Specialist

About the Role

Our client is seeking a vigilant and analytical Pharmacovigilance Specialist to join their dedicated safety team in Rustenburg, North West . In this critical role, you will be responsible for monitoring the safety profiles of pharmaceutical products post-marketing, ensuring patient safety is paramount. You will collect, assess, and report adverse event data, contributing to the ongoing safety evaluation of medicines. This position requires a sharp eye for detail, a strong understanding of regulatory requirements, and the ability to work effectively within a collaborative team environment in our Rustenburg office. You will be a key guardian of public health, safeguarding the integrity of our pharmaceutical offerings.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.


• Determine the seriousness and causality of reported adverse events.


• Prepare and submit regulatory safety reports (e.g., Periodic Safety Update Reports - PSURs) to health authorities.


• Conduct literature reviews to identify potential safety signals and emerging risks.


• Liaise with healthcare professionals, regulatory bodies, and internal departments regarding safety matters.


• Contribute to the development and maintenance of safety databases and standard operating procedures (SOPs).

Requirements

• Degree in Pharmacy, Medicine, Nursing, or a related healthcare/life science field.


• Minimum of 3 years of experience in pharmacovigilance or drug safety.


• Thorough knowledge of global pharmacovigilance regulations (e.g., GVP, FDA regulations).


• Experience with safety database systems (e.g., Argus, ArisG).


• Excellent analytical and critical thinking skills.


• Strong written and verbal communication abilities.

Benefits

• Competitive salary and annual bonus.


• Comprehensive medical aid and retirement fund contributions.


• On-site parking and easy access to public transport.


• Opportunities for professional development and specialized training in drug safety.


• A stable and secure work environment within a leading pharmaceutical company.


• Employee wellness programs and health screenings.

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