Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Summary: 

Responsible for the intake and triage, processing, evaluation and reporting of incoming Serious Adverse  Event (SAE) reports according to applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific instructions.  

Independently serves as Lead PVG Associate on complex studies, applying and providing guidance to  clients and team members on PVG best practices tailored to the applicable project, patient population,  investigational product and client. 

Serves in a mentorship/leadership role with minimal supervision and guidance. 

Job Responsibilities: 

Tasks may include but are not limited to: 

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,  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. 

Demonstration of Tempus Compass Values: 

Consistently strives to demonstrate the following Tempus Compass values: 

Recognizes that the team is always stronger than the individual  Seeks to inspire others by demonstrating consistently strong performance Treats people with respect regardless of role or point of view  Listens well and seek to understand before reacting  Provides candid, helpful and timely feedback to colleagues  Demonstrates curiosity about and contributes effectively to areas outside of their specialty Keeps the bigger picture in mind when making decisions  Never stops learning   Questions assumptions and offers suggestions for improvement  Focuses on results rather than process and seeks to minimize complexity when process is required Identifies and addresses root causes, not symptoms  Demonstrates poise in stressful situations  Strives to always do the right thing  Questions actions that are incongruent with Tempus Compass values  

Minimum Qualifications: 

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

Preferred Qualifications: 

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

 

#LI-SH1 #LI-Remote

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.

 

Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.