Pharmacovigilance Specialist - Drug Safety

Placements24; Randburg; On-site; ZAR 350,000 - 550,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Professional development

Job summary

Placements24 is seeking a Pharmacovigilance Specialist in Randburg, Gauteng to monitor safety of marketed and investigational products. You will collect, assess, and report adverse event data in compliance with global regulations, collaborating with Clinical Operations, Regulatory Affairs and Medical Affairs.

The ideal candidate has a Pharmacy/Nursing/Life Sciences degree and at least 2 years PV experience, with strong attention to detail and solid communication skills.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related field.
• Minimum 2 years of pharmacovigilance or drug safety experience.
• Solid understanding of global PV regulations (CIOMS, ICH).
• Experience with safety databases (Argus, ArisG) is desirable.
• Excellent attention to detail and data accuracy.
• Strong written and verbal communication skills.

Responsibilities

• Collect, process and assess AE reports from diverse sources.
• Ensure timely submission of safety reports to regulators and partners.
• Write case narratives and analyze AE data.
• Contribute to PV SOPs and regulatory submissions.
• Participate in signal detection and risk assessment with cross-functional teams.
• Stay updated on global PV regulations and guidelines.
• Assist in PSURs and safety sections for submissions.

Education

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

2+ years PV/Drug Safety experience

Attention to detail and accuracy

Strong written and verbal communication

Independent work and workload management

Analytical and problem-solving skills

Tools

Argus

ArisG

Job description

About the Role

Our client, a respected pharmaceutical company, is actively recruiting a diligent Pharmacovigilance Specialist to join their Drug Safety department in Randburg, Gauteng . This role is critical for monitoring the safety of marketed and investigational products, ensuring patient well-being. The successful candidate will be responsible for the collection, assessment, and reporting of adverse event data in compliance with global regulatory requirements. This is an outstanding opportunity to contribute to patient safety and pharmacovigilance efforts within a company that prioritizes ethical conduct and scientific rigor. You will work collaboratively with various internal departments and external stakeholders to maintain the safety profile of pharmaceutical products. The position demands a strong understanding of safety reporting regulations and meticulous attention to detail.

Key Responsibilities

• Collect, process, and assess adverse event (AE) reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate submission of safety reports to regulatory authorities and business partners.
• Perform case narrative writing and data analysis for adverse event reports.
• Contribute to the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs).
• Participate in signal detection and risk assessment activities.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Medical Affairs.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Assist in the preparation of safety sections for regulatory submissions and periodic safety update reports (PSURs).

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 2 years of experience in pharmacovigilance or drug safety.
• Solid understanding of global pharmacovigilance regulations (e.g., CIOMS, ICH guidelines).
• Experience with safety databases (e.g., Argus, ArisG) is highly desirable.
• Excellent attention to detail and accuracy in data handling and reporting.
• Strong written and verbal communication skills.
• Ability to work independently and manage workload effectively.
• Good analytical and problem-solving skills.

Benefits

Our client offers a competitive salary, comprehensive benefits package including medical aid, retirement fund, and opportunities for continuous professional development. This role in Randburg, Gauteng , provides a platform to grow within a key area of pharmaceutical development. Join our client's dedicated team and contribute to ensuring the safety and efficacy of medicines.