Identify and assess (validate) new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
This includes signal detection activities in safety platforms, including our Company signal detection system and routine and ad hoc data mining in PV Signal.
Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance.
Provide recommendations for further signal evaluation.
Work with key customers and business partners (Medical Safety Officers, Safety Scientists, and other Safety Physicians) in developing and implementing product-specific surveillance plans.
Participate as member of the matrix teams to address product specific safety issues, assist in the development of signal evaluation strategies, and participate in signal evaluation.
Communicate findings from routine and ad hoc signal detection and assessment activities.
Assist in the development and implementation of programmatic surveillance of adverse event reports for potential safety and product quality issues.
Assist in the evaluation of novel, computer-assisted tools, and methodologies for analysis of safety data, including piloting new data sources and methodologies.

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 and 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, adverse event dictionaries, core labeling, and Periodic Safety Review preparation
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
Ability to manipulate data in platforms such as Excel and SAS JMP (preferred)
Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis (preferred)
Knowledge of public health surveillance and tools (preferred)
Knowledge of statistics, or system analytics, information systems engineering, or machine learning (preferred)

Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Associate Director, Signal Detection Scientist

Key skills