Associate Medical Safety Director- Sponsor Dedicated
On-siteKaunas, Kaunas, Lithuania
Job Summary
Conduct aggregate reviews of safety information and lead signal detection and analysis by reviewing Signal Detection Reports and raising potential signals for team discussion. Perform medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, and Development Risk Management Plans. Review and contribute to benefit-risk evaluations for drugs in clinical trials and post-marketing, manage label development, and provide medical safety support for pharmacovigilance case processing teams. Represent safety findings in internal and external stakeholder meetings and attend Safety Governance meetings as needed. This role supports IQVIA's mission to accelerate the development of innovative medical treatments to improve patient outcomes worldwide.
Required Qualifications
- A medical degree from an accredited and internationally recognized medical school
- Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process
- Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature
- Experience in Signal detection, Aggregate reports and Risk management
- Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
- Ability to establish and meet priorities, deadlines, and objectives
- Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed
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