Pharmacovigilance Specialist

Placements24; Gqeberha; On-site; ZAR 500,000 - 750,000; Full time

Benefits offered by this job

Medical insurance

Training opportunities

Flexible leave

Job summary

Placements24 is seeking a meticulous Pharmacovigilance Specialist to join our safety surveillance team in Port Elizabeth. You will monitor, collect, and evaluate adverse event data to support patient safety and regulatory compliance.

The role requires a solid understanding of pharmacovigilance principles, SAHPRA reporting, and the use of safety databases. You will collaborate with Regulatory Affairs and Medical Affairs to ensure accurate safety information.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related field.
• Demonstrable experience in pharmacovigilance or drug safety monitoring.
• Solid understanding of pharmacovigilance regulations and reporting guidelines (e.g., SAHPRA).
• Proficiency with pharmacovigilance databases and safety reporting systems.
• Strong analytical, organizational and written communication skills.

Responsibilities

• Collect, assess, and document adverse event reports from various sources.
• Ensure timely and accurate reporting to regulatory authorities per requirements.
• Conduct signal detection to identify new safety concerns.
• Contribute to PSURs and risk management plans.
• Collaborate with Regulatory Affairs, Medical Affairs and external partners on safety matters.
• Maintain and update pharmacovigilance databases and documentation.

Skills

Pharmacovigilance

Regulatory reporting

Data management

Safety surveillance

Education

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

Tools

Pharmacovigilance databases

Safety reporting systems

Job description

About the Role

Our client is looking for a meticulous and proactive Pharmacovigilance Specialist to join their safety surveillance team in Port Elizabeth . This role is critical for ensuring the ongoing safety of pharmaceutical products by monitoring, collecting, and evaluating adverse event data. You will play a key part in maintaining regulatory compliance and contributing to the safe use of medicines within the population. The ideal candidate will have a strong understanding of pharmacovigilance principles and regulatory reporting requirements, working diligently to protect public health and uphold the company's commitment to patient safety and ethical product stewardship in the Eastern Cape region.

Key Responsibilities

• Collect, assess, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of safety information to regulatory authorities in accordance with national and international requirements.
• Conduct signal detection activities to identify potential new safety concerns for assigned products.
• Contribute to the preparation of periodic safety update reports (PSURs) and risk management plans.
• Collaborate with internal departments (e.g., Regulatory Affairs, Medical Affairs) and external partners on safety-related matters.
• Maintain and update pharmacovigilance databases and relevant documentation.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Demonstrable experience in Pharmacovigilance or drug safety monitoring.
• Solid understanding of pharmacovigilance regulations and reporting guidelines (e.g., SAHPRA).
• Proficiency in using pharmacovigilance databases and safety reporting systems.
• Strong analytical, organizational, and written communication skills.

Benefits

• Competitive annual salary with regular reviews.
• Comprehensive medical insurance and retirement savings plan.
• Opportunities for specialized training in pharmacovigilance and drug safety.
• Generous annual leave and flexible working conditions considered.
• A crucial role in safeguarding public health through vigilant drug safety monitoring.