Associate Director, Drug Safety Physician

• 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

• 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

• 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