Associate Director, Safety Scientist

The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.

Requirements

• Managing safety scientist activities across multiple product portfolios and/or indications
• Organizing, training and/or supporting junior safety scientists and fellows
• Supporting activities related to new drug applications and other regulatory filings
• Representing global patient safety at regulatory inspections
• Leading gap analysis to ensure alignment with changes in global regulations
• Strategizing and drafting of responses to regulatory inquiries on product safety issues
• Representing GPS in global program teams and associated cross functional teams and/or projects as needed
• Proactively providing guidance and educational training to GPS therapeutic teams
• Performing Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
• Project managing and authoring of safety documents
• Authoring safety sections on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents
• Manage portfolio of products/projects related to risk management

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health, dental, and vision coverage