Associate Medical Safety Director - Sponsor Dedicated

About the role

The growing Lifecycle Safety Medical team at IQVIA is expanding. As Associate Medical Safety Director, you take part in all aspects of medical safety activities for a dedicated sponsor, covering post-marketing safety, signal management, risk management and regulatory reporting.

Key responsibilities

• Provide and maintain post-marketing safety expertise for internal and external stakeholders, and maintain knowledge of the allocated product portfolios
• Conduct medical evaluation of post-marketing adverse drug reactions and contribute to signal management and benefit-risk evaluation
• Prepare and contribute to responses to health authority questions and periodic aggregate reports
• Contribute to safety reviews of study protocols, investigator brochures and other reference safety information, and act as internal consultant on pharmacovigilance support
• Lead signal detection and analysis, including strategy, frequency and timing, and raise potential signals for team discussion
• Review and contribute to IND annual reports, EU Periodic Benefit-Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports and US Periodic Reports
• Review and contribute to Development Risk Management Plans, EU Risk Management Plans and US Risk Evaluation and Mitigation Strategies
• Support label development, review and updates, and contribute to the Integrated Safety Summary or Common Technical Document
• Review and clarify trial-related adverse events and post-marketing adverse drug reactions, including narrative, coding, expectedness, seriousness and causality
• Present safety and clinical data findings to internal and external stakeholders and attend Safety Governance and other meetings

Required profile

• A medical degree from an accredited, internationally recognized medical school
• Around three years of clinical practice, plus two additional years in the pharmaceutical or associated industry, or an equivalent combination of education, training and experience
• Maintains knowledge of the assigned product portfolio, therapeutic area and recent literature

Required skills

• Knowledge of federal and local clinical research regulations, including GCP, clinical trials and safety guidelines
• Signal detection, aggregate reports and risk management experience
• Ability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues orally and in writing
• Ability to work under pressure, meet deadlines and build effective working relationships with colleagues, managers and clients