• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• •Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Develop knowledge of capabilities and limitations of various data sources.
• •Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by the company.
•Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.
• Proactively disseminates information to safety team members, providing context/urgency as applicable.
• Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues.
• Demonstrates alignment with core values
• Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician
• Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
• Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.
• Provide management and training for new staff on department practices and therapeutic area knowledge.
• Identifies gaps in overall processes and initiates change as appropriate.
Education: Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
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