Associate Director, Patient Safety & Pharmacovigilance Science

The role

The Safety Science Associate Director performs safety monitoring of assigned investigational and marketed products. This role handles safety governance, signal detection, and aggregate reporting while collaborating with safety physicians and cross-functional stakeholders.

What you will do

• Perform safety data analyses using case series reviews, data summaries and AE trend information
• Collaborate with safety physicians on signal detection and risk management activities
• Review medical and scientific literature for signal detection and aggregate reporting
• Develop and maintain components of Risk Management Plans and REMS
• Prepare and review aggregate safety reports for assigned products
• Provide safety input to statistical analysis plans and data analysis visualizations
• Author and review safety reports and regulatory deliverables
• Participate in safety governance meetings and support benefit-risk assessment meetings
• Contribute to and review safety sections of clinical documents
• Mentor, train and collaborate with junior scientists

Required qualifications

• BS/BA degree in related discipline
• 4+ years in experience in patient safety and pharmacovigilance in the capacity of a scientist
• At least 2 years of clinical development experience

Nice to have

• PhD, PharmD or other advanced degree in related discipline
• Training or equivalent experience in epidemiology or public health
• Experience in writing safety analyses, performing signal detection or safety surveillance, risk management and preparing responses to HA
• Authoring and review of periodic and ad hoc safety reports and clinical development documents
• Experience with industry standard pharmacovigilance data systems
• Experience with NDA/MAA filing

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.