Associate Medical Safety Director – Sponsor Dedicated

• Participate in all aspects of Medical Safety activities according to scope of work
• Provide and maintain pharmacovigilance and risk management expertise for internal and external stakeholders
• Maintain knowledge relevant to allocated product portfolios
• Conduct medical evaluation of post-marketing adverse drug reactions
• Review and contribute to signal management and benefit-risk evaluation for drugs in clinical trial and post-marketing settings
• Prepare and/or contribute to responses to health authority questions
• Review and contribute to periodic aggregate reports
• Contribute to safety review of study protocols, investigator brochures, and other reference safety information
• Serve as an internal consultant for medical support of pharmacovigilance operations
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of product safety profiles
• Lead signal detection and analysis, including detection strategy, frequency, and timing; review Signal Detection Reports and other data sources; raise potential signals for team discussion; and contribute to safety analysis reports and presentations
• Provide medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, and US Periodic Reports
• Provide medical review and contribution to Development Risk Management Plans, EU Risk Management Plans, and US Risk Evaluation and Mitigation Strategies
• Review and contribute to benefit-risk evaluations of drugs
• Provide safety oversight and contributions for label development, review, and updates
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Perform medical review and clarification of trial-related adverse events and post-marketing adverse drug reactions, including narratives, queries, coding, expectedness, seriousness, causality, and company summaries
• Serve as an internal consultant to pharmacovigilance case-processing teams
• Represent safety and clinical data review findings in internal and external stakeholder meetings
• Provide medical safety support, contributions, and attendance at Safety Governance and other meetings as needed

• 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, safety, good clinical practice, clinical trials, and pharmaceutical research processes
• 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; capacity to work under pressure; initiative, 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