Pharmacovigilance Officer

Placements24; Pretoria; Hybrid; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Remote work

Competitive salary

Health benefits

Professional development

Job summary

Placements24 is seeking a vigilant Pharmacovigilance Officer to join the safety surveillance team, ideally near Pretoria with a remote option. You will monitor the safety of pharmaceutical products after market release and manage adverse event data for regulatory reporting.

You will coordinate with Medical Affairs and Regulatory Affairs, prepare PSURs, and help develop pharmacovigilance procedures. A background in pharmacy or healthcare science with 3+ years in pharmacovigilance is preferred.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Nursing, Medicine or related healthcare science field.
• Minimum 3 years of experience in pharmacovigilance or drug safety.
• Proficiency in adverse event reporting systems and databases.
• Strong understanding of global pharmacovigilance regulations (SAHPRA, FDA, EMA).
• Excellent analytical, written and verbal communication skills.

Responsibilities

• Collect, process, and document adverse event reports from various sources.
• Assess causality and severity of reported adverse events using standard terminologies.
• Prepare and submit PSURs and other regulatory safety filings in a timely manner.
• Collaborate with internal departments (Medical Affairs, Regulatory Affairs) and external stakeholders on safety matters.
• Contribute to development and maintenance of pharmacovigilance procedures and training materials.

Skills

Pharmacovigilance

Adverse event reporting

MedDRA coding

Regulatory compliance

Communication skills

Education

Bachelor's or Master's degree in Pharmacy, Nursing, Medicine

Tools

Veeva/Argus Safety

MedDRA

Job description

About the Role

Our client is seeking a vigilant and knowledgeable Pharmacovigilance Officer to join their safety surveillance team, ideally based near Pretoria , with a remote work option. This role is critical for monitoring the safety of pharmaceutical products after they have been released into the market. You will be responsible for collecting, assessing, and reporting adverse event data to regulatory authorities, ensuring compliance with global safety reporting requirements. This is an excellent opportunity to contribute to patient safety by actively managing and mitigating risks associated with pharmaceutical therapies, working within a dedicated global team committed to upholding the highest standards of drug safety and regulatory compliance.

Key Responsibilities

• Collect, process, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Assess the causality and severity of reported adverse events, ensuring accurate coding using standard terminologies (e.g., MedDRA).
• Prepare and submit periodic safety update reports (PSURs) and other regulatory safety filings in a timely manner.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs) and external stakeholders on safety matters.
• Contribute to the development and maintenance of pharmacovigilance procedures and training materials.

Requirements

• Bachelor's or Master's degree in Pharmacy, Nursing, Medicine, or a related healthcare science field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Proficiency in adverse event reporting systems and databases.
• Strong understanding of global pharmacovigilance regulations (e.g., SAHPRA, FDA, EMA guidelines).
• Excellent analytical, written, and verbal communication skills, with high attention to detail.

Benefits

• Competitive annual salary and potential for bonus.
• Comprehensive health and wellness benefits.
• Flexible remote working arrangement.
• Professional development opportunities in the field of drug safety and regulatory affairs.

A crucial role in ensuring the safety and efficacy of pharmaceutical products for patients across South Africa and beyond.