Pharmacovigilance Specialist: Drug Safety & Compliance

Placements24; LegKraal Gate; On-site; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Career development

Job summary

Placements24 is seeking a dedicated Pharmacovigilance Specialist to join its safety team in Mahikeng, North West. You will monitor and evaluate adverse drug reactions, ensure regulatory reporting, and maintain safety databases to support patient safety.

The ideal candidate has a healthcare degree and ≥3 years in pharmacovigilance, with strong MedDRA coding, analytical skills, and the ability to work independently in a fast-paced environment.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of pharmacovigilance principles, processes, and global regulatory requirements (e.g., ICH E2A, E2B).
• Experience with adverse event reporting and safety database management systems.
• Proficiency in MedDRA coding.
• Excellent analytical, problem-solving, and critical-thinking skills.
• Strong written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Detail-oriented with strong organizational skills.

Responsibilities

• Receive, process, and evaluate adverse event reports from various sources.
• Ensure timely reporting of adverse events to regulatory authorities (e.g., SAHPRA).
• Maintain the pharmacovigilance database with accuracy and completeness.
• Perform case narrative writing and coding of adverse events using MedDRA.
• Participate in signal detection activities for safety concerns.
• Contribute to PSURs and other safety regulatory documents.
• Collaborate with Regulatory Affairs, Clinical Operations, and Medical Affairs on safety matters.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Assist in development/update of pharmacovigilance SOPs.
• Support regulatory inspections and audits related to pharmacovigilance.

Skills

Analytical skills

Problem solving

Communication skills

Attention to detail

Organizational skills

Education

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

Tools

MedDRA coding

Job description

Placements24 is seeking a dedicated Pharmacovigilance Specialist to join its safety team in Mahikeng, North West. You will monitor and evaluate adverse drug reactions, ensure regulatory reporting, and maintain safety databases to support patient safety.

The ideal candidate has a healthcare degree and ≥3 years in pharmacovigilance, with strong MedDRA coding, analytical skills, and the ability to work independently in a fast-paced environment.