Associate Medical Safety Director- Sponsor Dedicated (Home-Based)
Employer · IQVIA
Specialist doctor
Other health professional
Health services managerFull-timeBudapest
Our ever-growing Lifecycle Safety Medical team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes providing and maintaining of PV and risk management expertise, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management, and serving as an internal consultant for any medical support for pharmacovigilance operations.
Tasks
- Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Leads signal detection and analysis, including, signal detection strategy, frequency, and timing
- Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
- Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
- Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up
- Providing safety oversight and contribution for label development, review, and updates
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
- Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
- Representing safety and clinical data review findings during internal and external stakeholder meetings
- Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed