Senior Associate, Pharmacovigilance

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

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