Associate, Safety System
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2176764
Job Description Summary
The Associate, Safety System is responsible for the ongoing management and support of Safety Systems database, and associated safety applications, Analytics. The individual will provide technical expertise, support, and guidance to the PV&SRM department and participate in safety system projects including coordination of database change activities within Mirati supporting functions. In addition, the individual will respond to time-sensitive requests from internal and external stakeholders such as Business partners, Drug Safety/PV Scientists, Clinical Science and Regulatory Authorities. The Associate, Safety Systems may serve as the designated back up for Associate Director, Safety Systems.
- Serve as system administrator for Mirati Safety database (Argus), providing oversight to the Argus hosting provider, maintenance of safety database libraries, initiation of change control, system testing, as applicable in support of PV business needs.
- Implement and/or manage MedDRA and WHO Drug dictionary up-versioning and PV system upgrades/patches.
- Proactively collaborate with hosting vendor to investigate, identify, develop, communicate, and implement solutions in support of database requirements to optimize quality and efficiency of end user and/or system performance.
- Manage and escalate system issues with the safety vendors as needed.
- Author and manage PV system Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated forms.
- Manage and provide oversight on quality issues, deviation, and Corrective and Preventive Actions (CAPAs) associated with safety systems.
- Configure and retrieve data listing requests to support expedited reporting, monthly safety reviews, SAE reconciliation activities, periodic reports, and ad-hoc requests, as needed from safety database /or Pharmacovigilance Query (PVQ) tool.
- Support PV Operations, PV Medical, Safety Science, Signal Detection, and Risk Management activities (as pertaining to safety systems).
What is Required
- Bachelor's degree or higher in Life Sciences or Information Technology.
- Relevant industry experience (3+ years).
- Demonstrated understanding of PV processes, ability to translate into technical solutions and implementations within the PV system
- Thorough knowledge of Oracle Argus Safety System configurations including, but not limited to reporting rules, workflows, E2B gateways/XML, DTD profiles and aggregate reporting.
- Proficient in SQL and/or PL/SQL skills
- Hands-on experience using Pharmacovigilance Query (PVQ) tool or other Safety Database Querying tool(s)
- Proficiency in standard desktop software program (Word, Excel, Outlook, and Power Point)
- Experience with system validation and compliance with global regulations
- Knowledge of GCP and ICH Guidelines
- Highly organized and team worker.
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.