Pharmacovigilance Officer

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

Benefits offered by this job

Competitive salary

Health insurance

Retirement savings plan

Continuous learning opportunities

Durban office

Job summary

Placements24 in Durban seeks a diligent Pharmacovigilance Officer to monitor, detect, assess and prevent adverse effects from medicines. You will manage adverse event data, support regulatory compliance and contribute to patient safety from our Durban office.

The ideal candidate has 3+ years in pharmacovigilance, strong knowledge of ICH/CIOMS, and proficient English communication. Join a team committed to public health and drug safety.

Qualifications

• 3+ years in pharmacovigilance or drug safety.
• Knowledge of ICH/CIOMS guidelines.
• Experience with safety databases and reporting systems.
• Excellent written and verbal English communication.

Responsibilities

• Collect and evaluate adverse event reports.
• Enter safety data into PV databases per regulations.
• Prepare and submit PSURs and other safety reports.
• Collaborate with medical, regulatory, and clinical teams on safety issues.
• Monitor literature for new safety information.
• Help develop pharmacovigilance procedures and training.

Skills

Pharmacovigilance

Data entry

Regulatory compliance

Analytical thinking

Education

Bachelor's degree in Pharmacy, Nursing, Medicine

Tools

Safety databases

PSUR reporting systems

Job description

About the Role

Our client is seeking a diligent and detail-oriented Pharmacovigilance Officer to join their expanding safety surveillance team based in Durban . This critical role focuses on the monitoring, detection, assessment, and prevention of adverse effects related to pharmaceutical products. You will be instrumental in ensuring patient safety by managing and reporting adverse event data, contributing to regulatory compliance, and maintaining the highest standards of drug safety. This position offers a unique opportunity to contribute to public health by safeguarding the use of medicines within a reputable pharmaceutical company.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources, ensuring accuracy and completeness.
• Enter safety data into the pharmacovigilance database in compliance with company and regulatory requirements.
• Prepare and submit regulatory safety reports, including Periodic Safety Update Reports (PSURs).
• Collaborate with medical affairs, regulatory affairs, and clinical development teams on safety-related issues.
• Monitor relevant scientific literature and databases for new safety information on company products.
• Participate in the development and implementation of pharmacovigilance procedures and training materials.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, or a related healthcare/life science field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, CIOMS).
• Experience with safety databases and reporting systems.
• Strong analytical and problem-solving skills, with excellent attention to detail.
• Proficiency in English, with strong written and verbal communication abilities.

Benefits

• Competitive annual salary commensurate with experience.
• Comprehensive health insurance and retirement savings plan.
• Opportunities for continuous learning and professional growth in drug safety.
• A supportive work environment that prioritizes patient well-being and ethical practices.
• Contribution to global patient safety from our Durban office.