Associate Medical Safety Director iqvia

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, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate

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) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams

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