Assoc Director Safety Science

📋 Description

• Develop and maintain an understanding of the safety profile of assigned product(s) as well as
• Responsible for assisting/overseeing signal detection and management activities including, but not
• Responsible for the preparation and maintenance of safety sections of the ISMP, DSUR, IND Annual
• Present important safety issues to program teams for internal and external review.
• Serve as safety science representative for clinical trial team meetings or investigator/site
• Contribute to the drafting of safety assessments and drug safety reports for individual cases or

🎯 Requirements

• Healthcare professional degree (MD, PharmD, or RN) required
• 4 or more years of drug development experience in the pharmaceutical or related industry including
• Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and
• Demonstrated ability to lead and influence, with and without authority, in a fast paced environment
• Exposure to Safety Operations and experience with data entry and administration of drug safety
• Strong presentation skills, effective at summarizing and presenting the key considerations and

🎁 Benefits

• Paid Time Off
• Holiday, and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)