Medical Safety Director
Há 6 dias
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We strive to push the boundaries of human science and data science to make a significant impact on our customers' success.
Job DescriptionAssociate Medical Safety Director Role
We are looking for an Associate Medical Safety Director to provide medical, scientific, and therapeutic expertise on pharmacovigilance services. This role involves participating in all aspects of the Medical Safety activities:
- Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
- Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.
- Serving as an internal consultant to pharmacovigilance case processing teams on projects.
- Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile.
- Providing coding review of AEs, past medical history, concomitant medications, or other medical data listings to verify and medically vet clinical data.
- Representing safety and clinical data review findings during client meetings.
- Providing medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, and US Periodic Reports.
- Providing medical review and edits of Development Risk Management Plans, EU Risk Management Plans, or US Risk Evaluation and Mitigation Strategies.
- Providing medical oversight for label development, review, and change.
- Providing medical support and attendance at Data Safety Monitoring Board Meetings.
- Attending and contributing to medical safety evaluation on Safety Monitoring Committees.
RequirementsQualifications and Experience
- 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.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research, including safety and good clinical practice.
- Knowledge of clinical trials and the pharmaceutical research process.
- Experience in risk management, signal detection, and aggregate reports.
- Ability to establish and meet priorities, deadlines, and objectives.
- Demonstrated skills in providing consultation and advice on multiple assignments, as well as initiative and flexibility.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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Lisboa, Lisboa, Portugal TN Portugal Tempo inteiroAssociate Medical Director for Clinical SafetyWe are looking for an Associate Medical Director to provide medical, scientific, and therapeutic expertise on pharmacovigilance services. This role involves participating in all aspects of the Medical Safety activities, including:Performing medical review and clarification of trial-related Adverse Events (AEs)...
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