Pharmacovigilance Specialist - Drug Safety

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

About the Role

Our client, a reputable entity in the pharmaceutical industry, is seeking an experienced and dedicated Pharmacovigilance Specialist to bolster its drug safety team. This role, based in Mahikeng, North West , involves ensuring the safety and efficacy of marketed pharmaceutical products through diligent monitoring and reporting of adverse events. The specialist will play a key role in maintaining compliance with global pharmacovigilance regulations and contributing to risk management strategies. This position offers a hybrid work arrangement, providing a balance between essential on-site collaboration and flexible remote work. It is an excellent opportunity for a detail-oriented professional passionate about patient safety and regulatory compliance. Join our committed team in Mahikeng and contribute to safeguarding public health.

Key Responsibilities

• Collect, process, and document adverse event reports from various sources (e.g., healthcare professionals, patients, clinical trials).
• Ensure timely and accurate reporting of adverse events to regulatory authorities and internal stakeholders according to regulatory requirements.
• Conduct case assessment and review to determine causality and completeness of information.
• Participate in the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs).
• Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory safety submissions.
• Support risk management activities, including the identification and assessment of safety signals.
• Collaborate with internal departments (e.g., Clinical Operations, Regulatory Affairs, Medical Information) and external partners.
• Assist in the preparation for and participation in regulatory inspections and audits related to pharmacovigilance.
• Maintain proficiency in relevant pharmacovigilance databases and safety reporting systems.
• Stay updated on global pharmacovigilance regulations and guidelines.

Requirements

• A Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• A minimum of 3 years of experience in pharmacovigilance, drug safety, or a related role within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., ICH E2A/E2B, FDA, EMA, SAHPRA guidelines).
• Experience with adverse event data collection and reporting systems (e.g., 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.

Benefits

• Our client offers a competitive salary, performance-based incentives, and a comprehensive benefits package including medical aid, retirement fund contributions, and life assurance.
• The hybrid work model promotes a healthy work-life balance.
• Opportunities for professional development, including specialized pharmacovigilance training and certifications, are provided.
• This role is based in our facility in Mahikeng, North West , offering a professional and supportive work environment.
• Enjoy generous annual leave and the chance to grow within a company committed to patient safety and pharmaceutical integrity.