Hybrid PV Specialist: Drug Safety & Compliance

Placements24; LegKraal Gate; Hybrid; ZAR 680,000 - 860,000; Full time

Benefits offered by this job

Hybrid work model

Professional development in pharmacov‑

Medical aid and retirement fund

Job summary

Placements24 seeks a Pharmacovigilance Specialist to strengthen its drug safety team in Mahikeng, North West. This role focuses on monitoring adverse events, ensuring regulatory reporting, and maintaining PV systems.

It offers a hybrid work arrangement balancing on-site collaboration with remote flexibility. The ideal candidate has a Pharmacy/healthcare background with 3+ years PV experience, strong regulatory knowledge (ICH, FDA, EMA, SAHPRA) and excellent data handling skills to support PSURs

Qualifications

• 3 years of experience in pharmacovigilance, drug safety, or a related role within the pharmaceutical industry.
• Deep knowledge of global pharmacovigilance regulations (ICH E2A/E2B, FDA, EMA, SAHPRA).
• Experience with adverse event data collection and reporting systems (Argus Safety, ARISg).
• Strong understanding of medical terminology and case processing.
• Excellent analytical, problem-solving, and critical thinking skills.
• High level of accuracy and attention to detail in documentation and reporting.
• Effective written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment, managing multiple tasks efficiently.

Responsibilities

• Collect, process, and document adverse event reports from healthcare professionals, patients, and trials.
• Ensure timely reporting of adverse events to regulatory authorities and internal stakeholders.
• Conduct case assessment to determine causality and information completeness.
• Participate in development and maintenance of pharmacovigilance SOPs.
• Contribute to PSURs and other regulatory safety submissions.
• Support risk management activities including safety signals assessment.
• Collaborate with Clinical Operations, Regulatory Affairs, Medical Information, and external partners.
• Assist in regulatory inspections and audits related to pharmacovigilance.
• Maintain proficiency in PV databases and safety reporting systems.
• Stay updated on global PV regulations and guidelines.

Skills

Pharmacovigilance

Drug safety

Data analysis

Education

Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field

Tools

Argus Safety

ARISg

Job description

Placements24 seeks a Pharmacovigilance Specialist to strengthen its drug safety team in Mahikeng, North West. This role focuses on monitoring adverse events, ensuring regulatory reporting, and maintaining PV systems.

It offers a hybrid work arrangement balancing on-site collaboration with remote flexibility. The ideal candidate has a Pharmacy/healthcare background with 3+ years PV experience, strong regulatory knowledge (ICH, FDA, EMA, SAHPRA) and excellent data handling skills to support PSURs