Associate Director, Drug Safety Physician

🔥 6 hours ago

🌐 South Africa, Kenya, +1 more countries – Remote

🇿🇦 South Africa – Remote 🇰🇪 Kenya – Remote 🇳🇬 Nigeria – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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IAVI

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1996

🧬 Biotechnology

🏥 Healthcare

🤝 Non-profit

Biotechnology • Healthcare • Non-profit

IAVI is a global nonprofit biomedical research organization that develops vaccines and therapeutic antibodies for HIV, tuberculosis, and emerging infectious diseases. It pursues end-to-end product development—discovery, epidemiology, clinical development, product development, and global access—working through a network of academic, biotech, pharma, and public health partners. IAVI conducts preclinical and clinical trials, advances vaccine candidates (including rVSV-based vaccines for Lassa, Marburg, Sudan, and Bundibugyo viruses), supports broadly neutralizing antibody research for HIV, and engages in policy, advocacy, and community partnerships to ensure affordable, globally accessible public health solutions.

📋 Description

• Participate in the design and conduct of clinical trials to ensure appropriate collection and analysis of safety and efficacy data • Collaborate with clinical development, regulatory affairs, biostatistics, clinical operations, and other functional units • Contribute to regulatory submissions and respond to regulatory agency safety questions • Review and approve safety sections of clinical trial protocols and contribute to clinical study reports • Identify and assess investigational product safety risks and recommend mitigation strategies • Review and analyze adverse event reports, clinical trial data, and other safety information • Perform medical review, similar-event analysis, company causality and expectedness assessments, and MedDRA coding review for ICSRs • Contribute to signal detection and risk management • Contribute to DSURs, Investigator’s Brochure updates, signal detection reports, and Safety Management Plans • Oversee pharmacovigilance vendor activities through compliance reports and the PV unit Risk Register • Attend monthly PV vendor and internal project meetings • Attend IDMC and GSMB meetings as necessary • Ensure compliance with safety data exchange agreements and clinical trial agreements • Support reconciliation of clinical and safety databases • Approve documents for filing in the study-specific TMF • Support continuous process improvement initiatives within the Drug Safety and Pharmacovigilance unit • Interact with internal and external partners, stakeholders, investigators, and regulatory agencies on safety topics

🎯 Requirements

• MD or equivalent required • Minimum 5 years of experience in a clinical research role with at least 3 years in a drug safety role required • Experience and understanding of safety operations, safety regulations and clinical research principles required • Experience with HIV/infectious diseases or vaccine development preferred • Experience with clinical trials in Africa preferred • Strong organizational skills and ability to manage multiple projects with overlapping schedules • Ability to work independently and collaboratively in large, complex, cross-functional project teams • Attention to detail and ability to meet timelines in a fast-paced environment • Excellent verbal and written communication skills • Critical thinking skills and ability to identify problems, possible solutions, and timeline impacts • Ability to work effectively with teams of diverse educational and cultural backgrounds • Computer and technological literacy • Proficiency in Microsoft Office Suite and ability to learn new systems quickly • Good knowledge and experience with Medical Dictionary for Regulatory (MedDRA) coding of medical concepts

🏖️ Benefits

• Generous retirement savings plan employer contributions • Competitive health, dental and vision insurance plans • Competitive paid time off policy • Potential for annual bonuses based on performance • Salary paid in local currency and commensurate and competitive with the local labor market

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