Director of Data Stewardship Enablement Lead at GSK driving digital transformation across R&D. Focusing on empowering data stewardship and building a thriving community of practice.
About the role
- Associate Medical Safety Director overseeing medical safety evaluations and risk management strategies for clinical trials at IQVIA. Collaborating with stakeholders to ensure product safety and regulatory compliance.
Responsibilities
- 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
Requirements
- 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
Benefits
- Health insurance
- Pension plan
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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