Pharmacovigilance Specialist

Placements24; Rustenburg; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical aid and retirement fund

On-site parking

Professional development

Wellness programs

Job summary

Placements24 in Rustenburg is seeking a vigilant Pharmacovigilance Specialist to join the safety team. You will monitor post-marketing safety, assess reports, and ensure regulatory compliance.

Responsibilities include collecting adverse event data, preparing PSURs, coordinating with health authorities, and maintaining safety databases. A degree in healthcare and 3 years' experience are required; Argus/ArisG experience preferred.

Qualifications

• 3 years of experience in pharmacovigilance or drug safety
• Thorough knowledge of global pharmacovigilance regulations (e.g., GVP, FDA)
• Experience with safety database systems (Argus, ArisG)
• Strong written and verbal communication abilities

Responsibilities

• Collect, process, and evaluate adverse event reports from various sources
• Determine seriousness and causality of reported adverse events
• Prepare and submit regulatory safety reports (e.g., PSURs) to health authorities
• Conduct literature reviews to identify 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 SOPs

Skills

Pharmacovigilance

Analytical thinking

Regulatory awareness

Education

Degree in Pharmacy, Medicine, Nursing, or related field

Tools

Argus

ArisG

Job description

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.