Pharmacovigilance Specialist — Safety & Reporting Expert

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

Benefits offered by this job

Medical aid

Life insurance

Pension fund

Annual leave

Sick leave

Training and development

Job summary

Placements24 in Randburg, Gauteng, South Africa, is seeking a Pharmacovigilance Specialist to oversee AE collection, assessment, and regulatory reporting. You will work with regulatory affairs, medical affairs, and clinical operations to ensure drug safety and comply with ICH guidelines.

The role requires a Bachelor’s degree in a healthcare field and 3–5 years in pharmacovigilance, with strong data management and communication skills.

Qualifications

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences or related healthcare field.
• Minimum 3–5 years of experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles, AE case processing, and regulatory reporting requirements.
• Familiarity with ICH E2A, E2B, E2C guidelines.
• Experience with pharmacovigilance databases and safety reporting systems.
• Excellent attention to detail, organizational skills, and ability to manage multiple tasks.
• Strong written and verbal communication skills.
• Must be legally eligible to work in Randburg, Gauteng, South Africa.

Responsibilities

• Collect, assess, and document adverse event reports from various sources.
• Ensure timely and accurate reporting of safety information to regulatory authorities.
• Conduct literature searches for safety signals and emerging trends.
• Maintain and manage the pharmacovigilance database with data integrity.
• Prepare aggregate safety reports such as PSURs.
• Collaborate with internal departments and external partners for safety information.
• Contribute to the development and review of pharmacovigilance procedures.
• Assist in audits and inspections related to pharmacovigilance activities.
• Stay current with global regulatory requirements and guidelines.

Skills

Pharmacovigilance

AE processing

Regulatory reporting

ICH guidelines

Data management

Communication

Education

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

Tools

Pharmacovigilance databases

Safety reporting systems

Job description

Placements24 in Randburg, Gauteng, South Africa, is seeking a Pharmacovigilance Specialist to oversee AE collection, assessment, and regulatory reporting. You will work with regulatory affairs, medical affairs, and clinical operations to ensure drug safety and comply with ICH guidelines.

The role requires a Bachelor’s degree in a healthcare field and 3–5 years in pharmacovigilance, with strong data management and communication skills.