Overview In this role, you lead signal management activities to detect and evaluate safety signals from post-marketing data for complex products. You'll shape surveillance plans and collaborate with cross-functional teams to inform safety decisions. You'll explore novel data sources and tools to advance safety analytics within Innovative Medicine. This is a chance to impact patient safety and contribute to cutting-edge pharmacovigilance efforts at a global scale.
Compensation / Benefits- pension plan and 401(k)
- long-term incentive program
- vacation 120 hours per year
- sick time 40 hours per year
- Parental Leave 480 hours
- Bereavement Leave 240 hours
Responsibilities- Identify and assess new safety signals through systematic reviews of aggregate data, including signal detection in safety platforms and data mining in Empirica Signal
- Prepare topic reviews and summary analyses of safety data with minimal guidance
- Provide recommendations for further signal evaluation and communicate findings to stakeholders
- Collaborate with Medical Safety Officers, Safety Scientists, and Safety Physicians to develop product-specific surveillance plans
- Participate in matrix teams to address product safety issues and help shape signal evaluation strategies
- Support programmatic surveillance of adverse event reports for potential safety and product quality issues
- Evaluate novel tools and data sources, piloting new methodologies for safety data analysis
Key requirements- Bachelor degree in a healthcare-related discipline (minimum)
- 3 years of industry experience in pharmacovigilance/drug safety
- 1 year of clinical/patient-care experience preferred
- Understanding of global health authority regulations on adverse event processing and reporting
- Knowledge of post-marketing aggregate adverse event data reviews and adverse event dictionaries
- Familiarity with epidemiologic principles of case series evaluation; computer-assisted safety data analysis preferred
- Experience with MS Excel required; SAS JMP or similar platforms preferred
- Strong verbal and written communication, organization, and analytical skills
- Ability to lead projects and present complex data clearly in a global, matrix environment
- Up to 10% travel (domestic and international)
- strong communication skills
- excellent organization and analytical ability
- ability to lead projects and influence decision-making
- Empirica Signal
- MS Excel
- SAS JMP
