Remote Associate Director, Drug Safety Physician

IAVI; South Africa; Remote; ZAR 1,000,000 - 1,600,000; Part time

Job summary

IAVI in Cape Town, South Africa, seeks an Associate Director, Drug Safety Physician, for a 50% part-time role. The physician will work with the Head of Pharmacovigilance to oversee safety operations, vendor management, and regulatory interactions across HIV vaccine development.

Responsibilities include safety data analysis, regulatory submissions, MedDRA coding reviews, and risk management within a global PV unit. Remote-South Africa work is supported.

Qualifications

• MD or equivalent required.
• Minimum 5 years of experience in a clinical research role with at least 3 years in a drug safety role.
• Experience with HIV/infectious diseases or vaccine development preferred.
• Experience with clinical trials in Africa preferred.

Responsibilities

• Participating in the design and conduct of clinical trials to ensure safety and efficacy data are collected and analyzed appropriately.
• Collaborating with cross-functional teams to communicate safety and efficacy data to stakeholders.
• Contributing to regulatory submissions and responding to questions from regulatory agencies regarding product safety.
• Reviewing safety sections of protocols and contributing to safety sections of the clinical study report.
• Identifying and assessing safety risks and recommending mitigation strategies.
• Reviewing adverse event reports and safety data for trials sponsored by IAVI.
• Providing medical review and causality assessments including MedDRA coding reviews.
• Contributing to signal detection and risk management for assigned projects.
• Developing DSURs, Investigator’s Brochure updates, and Safety Management Plans as needed.
• Overseeing pharmacovigilance vendor and reviewing compliance reports.

Skills

Safety operations

Regulations

Organizational skills

Communication

Teamwork

Attention to detail

Critical thinking

Independence

Education

MD or equivalent

Tools

MedDRA coding

MS Office

Job description

IAVI in Cape Town, South Africa, seeks an Associate Director, Drug Safety Physician, for a 50% part-time role. The physician will work with the Head of Pharmacovigilance to oversee safety operations, vendor management, and regulatory interactions across HIV vaccine development.

Responsibilities include safety data analysis, regulatory submissions, MedDRA coding reviews, and risk management within a global PV unit. Remote-South Africa work is supported.