Sr. Safety Systems Associate
Department: 320 - Clinical Development : Richard Chao/Bill Bleker/ Ron Shazer/ Joe Leveque
Employment Type: Full Time
Reference Number: 1612445
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
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 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.
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.