Senior Drug Safety Associate – Remote (South Africa, US EST Hours)

About the role

We are looking for an experienced Senior Drug Safety Associate to join our South African team on a remote basis. The role works US EST hours and supports global pharmaceutical, biotech and medical‑device clients with safety case processing, narrative writing and regulatory compliance.

Key responsibilities

• Maintain up‑to‑date knowledge of drug safety regulations, guidelines and the clinical trial process.
• Lead projects independently, develop strategic safety narratives and negotiate directly with clients.
• Process safety cases from start to finish, ensuring high‑quality deliverables and compliance with internal and client SOPs.
• Create and update safety reports, manage client meetings and resolve feedback efficiently.
• Mentor junior staff and identify process efficiencies within the department.
• Utilise safety databases, perform MedDRA and WHO drug dictionary coding, and apply QC procedures.

Required profile

• University degree in a scientific, medical or clinical discipline (master’s or PhD preferred).
• Minimum 5 years of experience in drug safety or pharmacovigilance.
• Strong understanding of scientific principles, clinical trial workflows and regulatory requirements.
• Proven track record as an emerging leader with consistent performance.
• Excellent communication and problem‑solving abilities.

Required skills

• MedDRA coding
• WHO drug dictionary coding
• Safety database management
• Quality control processes
• MS Office suite
• Clinical trial processes
• Pharmacovigilance regulations

What we offer

• Opportunity to work with a globally recognised CRO.
• Collaborative and inclusive remote work environment.
• Exposure to diverse therapeutic areas and international clients.