Senior Drug Safety Physician Leader

Int'l AIDS Vaccine Inc.; Cape Town; Remote; ZAR 900,000 - 1,300,000; Part time

Job summary

IAVI is seeking an Associate Director, Drug Safety Physician in Cape Town, South Africa with remote work option. You will partner with the Head of Pharmacovigilance to oversee drug safety operations and vendor oversight, while collaborating across clinical development, regulatory, and operations.

This role supports safety review and regulatory submissions for HIV vaccines and related products. The position allows a 50% part-time allocation and requires MD or equivalent with 5+ years in clinical

Qualifications

• MD or equivalent required.
• Minimum 5 years 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 data are collected and analyzed appropriately.
• Collaborating with clinical development and regulatory affairs to communicate safety data to stakeholders.
• Contributing to regulatory submissions and responding to questions regarding product safety.
• Reviewing safety sections of protocols and clinical study reports; contributing to safety sections.
• Identify and assess safety risks of investigational products and advise on mitigation strategies.
• Reviewing adverse event reports and other safety information from trials sponsored by IAVI.
• Provide medical review and analysis of similar events and MedDRA coding for ICSRs.
• Contribute to signal detection and risk management for assigned projects.

Skills

Pharmacovigilance

Drug Safety

Clinical Trials

MedDRA coding

Regulatory Submissions

Safety Reviews

Signal Detection

Cross-functional Collaboration

MS Office

Education

MD or equivalent

Tools

MS Office

Job description

IAVI is seeking an Associate Director, Drug Safety Physician in Cape Town, South Africa with remote work option. You will partner with the Head of Pharmacovigilance to oversee drug safety operations and vendor oversight, while collaborating across clinical development, regulatory, and operations.

This role supports safety review and regulatory submissions for HIV vaccines and related products. The position allows a 50% part-time allocation and requires MD or equivalent with 5+ years in clinical