Lead the implementation of the Signal Management Group aggregate surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends
Develop and implement product-specific surveillance plans
Perform post-marketing signal detection activities, including signal validation
Participate in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings
Develop strategies for signal evaluation, including providing guidance on data sources and methods of analysis
Conduct systematic reviews of aggregate data with a focus on spontaneous adverse event reports
Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance
Work with key customers and business partners (Medical Safety Officers, Safety Scientists, and other Safety Physicians) in developing and implementing product-specific surveillance plans

Bachelor’s Degree required
Advanced Healthcare-related Degree (e.g., RN, BSN, PharmD) with 3+ years industry experience in pharmacovigilance/drug safety or related area
1+ year of clinical/patient-care experience highly preferred
Understanding of global health authority regulations and guidance surrounding the processing, reporting, and evaluation of adverse events
Understanding single case medical assessment, post-marketing aggregate adverse event data reviews, evaluations of drug safety issues
Ability to lead projects
Skillful in presenting complex data in a concise and understandable scientific manner
Ability to thrive in a global, matrix environment – able to handle high workload and critical issues
Up to 10% travel – Domestic & International

120 hours vacation per calendar year
40 hours sick time per calendar year
13 days holiday pay per calendar year
480 hours parental leave within one year of the birth/adoption/foster care of a child
240 hours bereavement leave for an immediate family member
80 hours caregiver leave in a 52-week rolling period
32 hours volunteer leave per calendar year
80 hours military spouse time-off per calendar year

Associate Director, Signal Detection Scientist

Key skills