IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Medical Director, Medical Safety Assessment
Department Title and Description
Medical Safety Assessment, Global Pharmacovigilance & Epidemiology Research & Development
Purpose/Objective of the job
Leads all medical safety assessment and related activities for assigned molecules
Key Responsibilities and Major Duties
• Leads Medical Surveillance Teams,
• In the area of Signal Detection/Safety surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world, to understand and manage safety signals
• Accountable for risk strategy, risk assessment and risk minimization for company products in partnership with other company functions.
• Serve as safety consultant for product development activities.
• Leader or key contributor to safety query responses.
• Medical safety lead for aggregate safety reports and strategic documents
• Serve as a trusted partner to other R&D functions in representing the view on product safety, and lead in a matrix environment through scientific competency and organizational influence and impact.
• Contributes to GPVE and cross functional improvement initiatives
Internal Matrix: Safety Scientist, Aggregate Reports and Document Lead, Epidemiologist, Clinical Safety Program Lead, Medical Review Safety Physician, Therapeutic Area Head, Administrative Assistants
External Matrix: Medical Team Leads, Development team leads, Medical Monitors, Global and Regional Regulatory Leads Global Biometric Science Lead (Global Biometric Science), Operation Lead, Pre-Clinical Safety Lead (Drug Safety Evaluation), Labeling Lead, Medical Global Clinical Research Leads, Project Management as appropriate to stage of development
MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.
Experience - Responsibility and minimum number of years
Generally, has 3 or more years previous experience as medical safety assessment physician
Competencies - knowledge, skills, abilities, other
• Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
• Strong written and oral scientific communication skills
• Strong scientific analytical reasoning skills
• Behavioral competencies necessary to work and lead within a complex matrix environment
• Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
• Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
• Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
• Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.