Pharmacovigilance Officer

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 360.000 - 520.000; Vollzeit

Zusammenfassung

Placements24 is seeking a vigilant Pharmacovigilance Officer to monitor adverse events and ensure regulatory compliance across South Africa. This remote role supports Mpumalanga and beyond, focusing on data collection, assessment, and timely safety reporting to SAHPRA and other authorities.

The ideal candidate holds a degree in Pharmacy, Medicine, or a life science, with at least two years in pharmacovigilance, strong analytical skills, and the ability to work independently in a remote setup.

Qualifikationen

• Degree in Pharmacy, Medicine, Nursing, or life science.
• Minimum 2 years in pharmacovigilance or drug safety.
• Understanding of GVP, ICH guidelines, SAHPRA regulations.
• Experience with pharmacovigilance databases and safety reporting systems.
• Strong analytical and communication skills; able to work remotely.

Aufgaben

• Collect, review, and assess adverse event reports from healthcare professionals, patients, and trials.
• Ensure timely submission of safety reports to regulatory authorities (SAHPRA).
• Maintain the pharmacovigilance database with accurate safety information.
• Participate in signal detection activities for potential safety issues.
• Prepare PSURs and risk management plans (RMPs).
• Liaise with cross-functional teams and external partners on pharmacovigilance matters.

Kenntnisse

Pharmacovigilance

Regulatory compliance

Data analysis

Remote work

Communication

Ausbildung

Degree in Pharmacy, Medicine, Nursing or life sciences

Tools

Pharmacovigilance databases

SAHPRA reporting systems

Jobbeschreibung

About the Role

Our client is seeking a vigilant and experienced Pharmacovigilance Officer to ensure the safety of their pharmaceutical products through rigorous monitoring and reporting of adverse events. This role, based remotely, is essential for maintaining regulatory compliance and protecting patient well-being across Mpumalanga and beyond. You will be responsible for the collection, assessment, and reporting of adverse event data, contributing to the ongoing safety profile assessment of medicinal products. This is a critical position within the pharmaceutical industry , requiring a strong commitment to patient safety and regulatory adherence in a flexible, remote working setup .

Key Responsibilities

• Collect, review, and assess adverse event reports from various sources, including healthcare professionals, patients, and clinical trials.
• Ensure timely and accurate submission of safety reports to regulatory authorities, such as SAHPRA.
• Maintain the pharmacovigilance database, ensuring all safety information is accurately recorded and updated.
• Participate in signal detection activities, identifying potential safety issues related to pharmaceutical products.
• Contribute to the preparation of periodic safety update reports (PSURs) and risk management plans (RMPs).
• Liaise with internal departments and external partners regarding pharmacovigilance matters.

Requirements

• Degree in Pharmacy, Medicine, Nursing, or a related life science discipline.
• Minimum of 2 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Thorough understanding of pharmacovigilance principles, processes, and regulatory requirements (e.g., GVP, ICH guidelines, SAHPRA regulations).
• Experience with pharmacovigilance databases and safety reporting systems.
• Strong analytical and critical thinking skills, with excellent attention to detail.
• Excellent written and verbal communication skills, with the ability to work independently in a remote setting .

Benefits

• Competitive annual salary and comprehensive benefits package.
• Flexible and remote working arrangements .
• Opportunities for professional growth and specialized training in pharmacovigilance.
• Contribution to ensuring the safety and efficacy of pharmaceutical products.
• Supportive work culture focused on collaboration and compliance within the pharmaceutical sector .