Tempus Labs, Inc. is hiring a
Senior Associate

Summary

The job is for a Pharmacovigilance Lead Associate at Tempus, responsible for intake, triage, processing, evaluation, and reporting of incoming SAE reports according to regulatory guidelines. The role involves leading complex studies, mentoring team members, and demonstrating Tempus Compass values.

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

Lead/Perform independently, with minimal guidance and oversight: 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, 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

Benefits

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status