Tempus Labs, Inc. is hiring a
Senior Associate

Summary

Join a team passionate about precision medicine and advancing the healthcare industry. As a PVG Associate Lead, you will be responsible for the intake and triage of Serious Adverse Event (SAE) reports, processing, evaluation, and reporting according to applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs), and project-specific instructions.

Requirements

• Bachelor’s degree in a life-science or healthcare related field
• Minimum of 5+ years of drug safety/pharmacovigilance experience (pre-approval clinical trials)
• Equivalent combination of relevant education and experience
• Proficient in Microsoft Word and Excel
• Excellent written and verbal communication skills
• Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines
• Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of global safety regulations and of applicable reporting requirements
• Able to proactively anticipate needs and follow through on all assigned tasks
• Ability and willingness for potential limited travel as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting)
• Oncology experience

Responsibilities

• Develop and implement project-specific Safety Management Plans and associated safety documents
• Complete safety database configuration and testing
• Attend internal and client meetings as appropriate
• Attend and present at Investigator Meetings
• Review incoming SAE reports for completeness/accuracy
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
• Proficient MedDRA and WHO Drug coding
• Generate queries for missing or unclear information and follow-up with sites for resolution
• Perform quality control (QC) review of SAEs processed by other PV Associates
• Generate regulatory reports and perform safety submissions as needed
• Prepare and submit periodic safety reports as needed
• Generate and monitor compliance metrics for assigned projects to ensure regulations and timelines are being met for expedited and periodic reporting
• Maintain knowledge and understanding of safety related regulations and guidelines
• Maintain strong understanding of PVG portion of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
• Participate in bid defenses or other presentations
• Mentor or train new PV staff
• May participate (support, review, draft, provide input, etc.) in strategic department development initiatives
• Perform other duties as assigned

Preferred Qualifications

• Prior experience working for both a sponsor company and a clinical research organization (CRO)
• Argus Safety Database experience