Associate Director, Drug Safety Physician

This is a fully remote position, open to applicants in South Africa, +2 more countries.

📋 Description

• Engage in the design and execution of clinical trials to ensure the proper collection and analysis of safety and efficacy data.

• Work collaboratively with clinical development, regulatory affairs, biostatistics, clinical operations, and other functional teams.

• Assist in regulatory submissions and address safety inquiries from regulatory agencies.

• Review and authorize safety sections of clinical trial protocols and contribute to the development of clinical study reports.

• Identify and evaluate safety risks associated with investigational products and propose mitigation strategies.

• Review and analyze adverse event reports, clinical trial data, and other safety-related information.

• Conduct medical reviews, similar-event analyses, company causality assessments, expectedness evaluations, and MedDRA coding reviews for Individual Case Safety Reports (ICSRs).

• Participate in signal detection and risk management activities.

• Contribute to Development Safety Update Reports (DSURs), updates to the Investigator’s Brochure, signal detection reports, and Safety Management Plans.

• Oversee pharmacovigilance vendor activities through compliance reports and the Pharmacovigilance (PV) unit Risk Register.

• Attend monthly meetings with PV vendors and internal project teams.

• Participate in Independent Data Monitoring Committee (IDMC) and Global Safety Management Board (GSMB) meetings as required.

• Ensure adherence to safety data exchange agreements and clinical trial agreements.

• Assist in reconciling clinical and safety databases.

• Approve documents for submission to the study-specific Trial Master File (TMF).

• Support ongoing process improvement initiatives within the Drug Safety and Pharmacovigilance unit.

• Collaborate with internal and external partners, stakeholders, investigators, and regulatory agencies on safety matters.

⛳️ Requirements

• MD or equivalent degree is mandatory.

• A minimum of 5 years of experience in a clinical research role, including at least 3 years in a drug safety capacity, is required.

• In-depth experience and knowledge of safety operations, safety regulations, and clinical research principles are essential.

• Experience with HIV/infectious diseases or vaccine development is preferred.

• Familiarity with conducting clinical trials in Africa is preferred.

• Strong organizational skills with the ability to manage multiple projects that have overlapping timelines.

• Capability to work both independently and collaboratively within large, complex, cross-functional project teams.

• Attention to detail and the ability to meet deadlines in a dynamic environment are crucial.

• Excellent verbal and written communication skills are necessary.

• Strong critical thinking skills with the ability to identify issues, propose solutions, and assess timeline impacts.

• Ability to effectively collaborate with teams from diverse educational and cultural backgrounds.

• Proficiency in computer and technological skills.

• Strong command of Microsoft Office Suite and the ability to quickly adapt to new systems.

• Solid understanding and experience with Medical Dictionary for Regulatory Activities (MedDRA) coding of medical concepts.

🏝️ Benefits

• Generous employer contributions to retirement savings plans.

• Competitive health, dental, and vision insurance options.

• Competitive paid time off policy.

• Potential for annual performance-based bonuses.

• Salary offered in local currency and is commensurate with the competitive local labor market.