Title: Senior Manager/Associate Director, Safety Scientist
Location: New York, NY
If you are interested in the below position, please send your resume to email@example.com and reference the position title within the subject line.
The Senior Manager/Associate Director, Safety Scientist plays a pivotal role within Global Pharmacovigilance and Drug Safety to ensure safety assessment for assigned TG Therapeutics, Inc investigational and/or marketed drug product(s) by leading signal detection activities and managing the emerging safety profile of his/her assigned drug product(s) in collaboration with the Safety Physician and under the direction of a senior level safety scientist’s guidance.
The Safety Scientist’s primary responsibility is to assimilate and synthesize safety data from various sources in support of safety-related deliverables, including signal detection and risk management activities, throughout the product’s lifecycle. This includes preparation of safety reports and delivering presentations, project managing signal detection and safety management teams, and communicating changes in the product risk profile to internal and external stakeholders.
––Provides support to Safety Physician in activities relating to monitoring and management of investigational and/or marketed product’s emerging safety profile
––Leads signal detection activities (evaluation and tracking) by conducting ongoing review of safety data for his/her assigned drug product(s)
––Assists Safety Physician to establish and manage signal detection and safety management teams, including implementation plan, meeting materials, and minutes
––Assists Safety Physicians in the development of risk management strategies
––Develops and maintains the risk management plan in accordance with regulatory requirements with input from cross-functional team members
––Contributes to risk information in aggregate safety reports (e.g. DSUR, PSUR/PBRER, PADER, etc.) and ensures consistency of the safety profile across key safety documents
––Reviews and contributes to the safety sections of Investigator’s Brochures and other clinical trial documents such as protocols and informed consents in collaboration with the Safety Physician
––Assist Safety Physician in developing a strategy for safety-related regulatory activities such as safety information requests from a health authority
––May support activities related to NDAs/BLAs and other regulatory submissions
––Possesses strong clinical or therapeutic area knowledge with at minimum 3 years of experience with an advanced degree or at least 5 years of experience with a Bachelor’s degree in the pharmaceutical or biotech industry
––Extensive knowledge of drug development and FDA, ICH and GxP regulations and guidances
––Thinks strategically: identifies critical issues by using basic knowledge of pharmacovigilance/drug safety to identify and action key issues or escalate as needed
––Acts decisively: shows competence to make appropriate and effective decisions within the scope of assigned tasks and projects
––Drives performance: holds accountability and seeks feedback as needed
––Works collaboratively: obtains input from others to gain consensus on a position, help explore an idea or build a solution
––Develops people and organization: takes responsibility for own development needs by seeking and acting on feedback
––Excellent oral and written communication skills to effectively interface with internal and external stakeholders, including but not limited to pharmacovigilance/drug safety system concepts and their applications
––Well organized and excellent attention to detail and time management skills as well as manage multiple priorities in a dynamic working environment
Advanced degree (e.g. PharmD, MSN) preferred, Bachelor’s degree in healthcare or related fields at minimum required