Pharmacovigilance Specialist

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

About the Role

Our client, a leading pharmaceutical company, is seeking a diligent and detail-oriented Pharmacovigilance Specialist. This role is based in Randburg , Gauteng, and is critical for ensuring the safety of our pharmaceutical products. You will be responsible for the collection, assessment, and reporting of adverse event data, ensuring compliance with regulatory requirements and company policies. The Pharmacovigilance Specialist will work closely with regulatory affairs, medical affairs, and clinical operations teams to monitor and manage product safety profiles. This position requires a strong understanding of pharmacovigilance principles, regulatory reporting, and data management. We are looking for a proactive individual who can contribute to maintaining the highest standards of patient safety. The Randburg location offers a central and accessible base for our safety operations.

Key Responsibilities

• Collect, assess, and document adverse event (AE) reports from various sources, including spontaneous reports, clinical trials, and literature.
• Ensure timely and accurate reporting of safety information to regulatory authorities (e.g., SAHPRA) and other stakeholders.
• Conduct literature searches for safety signals and emerging trends.
• Maintain and manage the pharmacovigilance database, ensuring data integrity and compliance.
• Participate in the preparation of aggregate safety reports, such as Periodic Safety Update Reports (PSURs).
• Collaborate with internal departments and external partners to gather necessary safety information.
• Contribute to the development and review of pharmacovigilance procedures and policies.
• Assist in audits and inspections related to pharmacovigilance activities.
• Stay current with global regulatory requirements and guidelines related to pharmacovigilance.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3-5 years of experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles, AE case processing, and regulatory reporting requirements.
• Familiarity with relevant regulatory guidelines (e.g., ICH E2A, E2B, E2C).
• 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.
• Ability to work effectively both independently and as part of a team.
• Proficiency in standard office software (e.g., Microsoft Office Suite).
• Must be legally eligible to work in Randburg , Gauteng, South Africa.

Benefits

• Competitive annual salary of ZAR.
• Comprehensive medical aid and life insurance.
• Opportunities for professional development and training in pharmacovigilance.
• Contributory pension fund.
• Generous annual leave and sick leave benefits.
• Exposure to a diverse portfolio of pharmaceutical products.
• Supportive and collaborative work environment.