Pharmacovigilance Specialist

Placements24; Bloemfontein; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary with overtime

Health, dental, and vision insurance

Retirement plan with company贡献

Professional development opportunities

Flexible remote work arrangement

Job summary

Placements24 is seeking an experienced Pharmacovigilance Specialist to join a remote safety team. You will collect, assess, and report adverse events, perform causality assessments, and support risk management plans for a global pharmaceutical portfolio.

The role requires a Pharmacy or life science degree with at least 3 years in pharmacovigilance, strong regulatory knowledge, and the ability to work independently in a remote environment. SA candidates welcome.

Qualifications

• Degree in Pharmacy, Nursing, Medicine, or related life science field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Proficiency with safety databases (e.g., Argus, Arisg) and data entry standards (e.g., MedDRA, WHODrug).
• Strong understanding of global pharmacovigilance regulations and guidelines.
• Excellent analytical, written, and verbal communication skills.
• Ability to work independently in a remote work environment.

Responsibilities

• Collect, review, and process adverse event reports from various sources.
• Perform medical assessment of adverse event reports, including causality assessment and seriousness evaluation.
• Ensure timely submission of safety reports to regulatory authorities and internal stakeholders.
• Maintain and update safety databases according to regulatory requirements and SOPs.
• Participate in PSURs/PBRERs and risk management plans (RMPs).
• Collaborate with clinical operations, regulatory affairs, and medical affairs teams on safety matters.
• Stay informed about global pharmacovigilance regulations and guidelines.

Skills

Pharmacovigilance

Drug safety

Adverse event assessment

Regulatory awareness

Education

Pharmacy degree

Related life science degree

Tools

Argus

Arisg

MedDRA

WHODrug

Job description

About the Role

Our client is seeking a diligent and experienced Pharmacovigilance Specialist to join their dedicated safety team, operating on a remote basis. This role is essential for safeguarding public health by ensuring the safe use of pharmaceutical products through proactive monitoring and reporting of adverse events. You will be responsible for collecting, assessing, and reporting safety data, contributing to the ongoing risk-benefit assessment of marketed and investigational drugs. This remote position allows you to make a significant impact on patient safety from anywhere, working within a global organization that prioritizes ethical conduct and scientific rigor in drug safety surveillance.

Key Responsibilities

• Collect, review, and process adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Perform medical assessment of adverse event reports, including causality assessment and seriousness evaluation.
• Ensure timely submission of safety reports to regulatory authorities and internal stakeholders.
• Maintain and update safety databases according to regulatory requirements and company SOPs.
• Participate in the development and review of periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).
• Collaborate with clinical operations, regulatory affairs, and medical affairs teams on safety-related matters.
• Stay informed about global pharmacovigilance regulations and guidelines.

Requirements

• Degree in Pharmacy, Nursing, Medicine, or a related life science field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Proficiency with safety databases (e.g., Argus, Arisg) and data entry standards (e.g., MedDRA, WHODrug).
• Strong understanding of global pharmacovigilance regulations and guidelines.
• Excellent analytical, written, and verbal communication skills.
• Ability to work independently, manage workload effectively, and meet strict deadlines in a remote work environment.

Benefits

• Competitive annual salary with potential for overtime compensation.
• Comprehensive health, dental, and vision insurance plans.
• Retirement savings plan with company contributions.
• Professional development opportunities and support for continuing education.
• Flexible remote work arrangement enabling a healthy work-life balance.