Associate Director, Drug Safety Physician (50% Full-Time Employee) at IAVI

• The Drug Safety Physician in collaboration with the Head of Pharmacovigilance, and PV Specialist will assist with daily drug safety operational activities.  A unique opportunity at a 50% part-time allocation, the Physician will collaborate cross-functionally with clinical development, regulatory, biostatistics, and clinical operations while overseeing and the pharmacovigilance vendor.  The Physician interacts with internal and external partners, stakeholders, investigators, as well as regulatory agencies on safety topics as necessary.
• Help IAVI translate science into global health solutions – learn more and apply below!

Key Responsibilities:

• Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately
• Collaborating with other functional units/departments within the company, such as clinical development, regulatory affairs, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders
• Contributing to the preparation of regulatory submissions and as necessary responding to questions from regulatory agencies regarding the safety and products in development
• Reviewing and approving, as necessary, safety sections of clinical trial protocols and contributing to safety sections of the clinical trial report
• Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks
• Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to products being evaluated in clinical trials sponsored by IAVI or situations where IAVI has safety reporting obligations
• Provide medical review and completion of analysis of similar events, company causality assessment, and expectedness assessment including review of MedDRA coding for individual safety case reports (ICSRs)
• Contribute to signal detection and risk management for assigned projects.
• Contribute to development of aggregate reports, (DSURs), Investigator’s Brochure updates, Signal detection reports, Safety Management Plans as necessary
• Contribute to oversight of the Pharmacovigilance vendor by reviewing operational compliance reports and the PV Risk Register
• Attending monthly project meetings with the PV vendor and the various internal project teams
• Attending Independent Data Monitoring Committee (IDMC) and Global Safety Monitoring Board (GSMB) meetings as necessary
• Assist with ensuring compliance with the requirements of safety data exchange agreements or safety data exchange in clinical trial agreements
• Support the data management team, as necessary, with periodic reconciliation of the clinical and safety databases for assigned projects

Approve documents requiring filing in the study specific TMF, as necessary

Support the ED Drug Safety and Pharmacovigilance with continuous process improvement initiatives within the Drug Safety and PV unit.

Education and Experience:

• 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 with HIV /infectious diseases or vaccine development preferred
• Experience with clinical trials in Africa preferred

Qualifications and Skills:

• Experience and understanding of safety operations, safety regulations and clinical research principles is required.
• Strong organizational skills, including the ability to work on multiple projects with overlapping schedules and flexibility, as well as to be able to change priorities to meet deadlines and organizational needs.
• Ability to work both independently and collaboratively in large, complex, cross-functional project teams.
• Attention to detail is required and ability to meet timelines in a fast-paced environment.
• Excellent verbal and written communication skills are required.
• Critical thinking skills, with the ability to identify problems and possible solutions, and assess impact on timelines is required.
• Ability to work effectively with teams of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI is required.
• Computer and technological literacy, proficiency in Microsoft Office Suite, and ability to quickly learn and master new systems is required.
• Good knowledge and experience with Medical Dictionary for Regulatory (MedDRA) coding of medical concepts