Sr. Safety Systems Associate
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1746643
Job Description Summary
Mirati is looking for a Senior Safety Systems Associate to join our growing team. This position is primarily responsible for performing all pharmacovigilance (PV) Systems activities for both the US & Globally. Responsibilities include maintenance of Argus & PVQ systems, supporting PV Operations and performing audit related activities. The individual will be responsible to maintain all updates on Industry/ Regulatory standards for PV systems. He / She will be responsible for implementation of new PV applications to support PV Operations, Signal Detection and Risk Management activities. The successful candidate will have the ability to work independently and also as a part of the team. The successful candidate will have the ability to work in a dynamic, changing environment to meet corporate and patient needs.
- Collaborate with database hosting vendor to implement system changes (e.g., study/product configurations, user access requests, etc.,) as needed to support PV business needs.
- Collaborate with database hosting vendor to upgrade MedDRA and WHO Drug dictionaries for Argus Safety Database as per PV requirements.
- Responsible for tracking all managed service tickets and ensuring timely and adequate follow-up from the database hosting vendor.
- Perform UAT testing as needed for any PV system.
- Perform Disaster Recovery activities for Argus and PVQ on a periodic basis.
- Provide overview training on Argus safety database to new PV staff and perform user account maintenance review on a periodic basis.
- Liaise with partners to implement and support XML transmission activities.
- Configure and retrieve data listing requests to support expedited reporting, monthly safety reviews, SAE reconciliation activities, periodic reports and ad-hoc requests, as needed.
- Management of Argus Safety database upgrades including interfacing with the database hosting vendor and Mirati IT & Quality Assurance.
- Setting up Electronic E2B gateways for submissions to Health Authorities.
- Partnering with Mirati Data Management to setup electronic SAE reporting from the clinical database (RAVE).
- Support internal audit/inspection activities by providing data listings from Argus/PVQ.
- Ensuring pre-approval inspection readiness regarding all necessary Argus/PVQ documents.
- Preparation and management of necessary SOPs related to Argus/PVQ.
- Selection and implementation of data visualization and analytics software (e.g., Spotfire) for signal detection activities.
- Perform routine regulatory intelligence activities related to changes in impacting PV systems.
What is Required
- At least 5 years' experience in a Safety systems role in the pharmaceutical industry with focus on knowledge of Argus console configurations and maintenance.
- Bachelor's degree or higher in life science or computing degree
- Knowledge of PV systems and processes (Argus, Cognos etc.)
- Knowledge of GCP and ICH Guidelines
- Proficient in Microsoft Office products (including Word and Excel)
- Experience with SQL and/or PL/SQL required
- Knowledge of GxP software applications
- Knowledge of Data visualization and analytics software
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.