Sr. Drug Safety Associate
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1666025
Job Description Summary
The Senior Drug Safety Associate will provide support for Mirati Safety Operations including QC/ QA of Individual Case Safety Reports (ICSRs), SAE reconciliation, signal detection, literature surveillance, and support other Pharmacovigilance activities as needed. Responsible for day-to-day Quality review of ICSR's including Narratives, Product coding, Medical coding, other case fields and for any possible discrepancies with the related source documents.
- Review and update follow-up queries as appropriate.
- Review regulatory reports required for ICSR submissions on a case by case basis.
- Perform SAE reconciliation with appropriate CRO data management personnel and Mirati team members as applicable.
- Address any case-processing related queries during CRO/partner reconciliation.
- Review, update and maintain Data Entry Guidelines as applicable.
- Serve as the Compound lead to address any questions related to SAE reconciliation activities. Provide SAE reconciliation metrics/compliance updates during study meetings.
- Assist with Literature surveillance activities.
- Perform User acceptance testing in the safety database development environment for data-entry related changes before rolling to production.
- Support signal detection and evaluation activities in accordance with SOPs and guidelines.
- Develop and maintain Pharmacovigilance SOPs/work instructions as required.
- Ensure audit preparedness and support regulatory inspections.
- Under the direction/review of senior PV staff, participate in other PV and Risk Management activities, as needed.
What is Required
- Bachelors' Degree or higher nursing, pharmacy or related health care field (required).
- At least 7 - 8 years' experience in a drug safety/pharmacovigilance case processing role with minimum 4 years' experience as ICSR Quality Reviewer.
- Relevant experience in the oncology therapeutic area, preferred.
- Experience needed with drug safety database (ARGUS, preferred).
- Experience with coding verbatim AE terms, medical history, laboratory data, and products using MedDRA and WHO-Drug dictionaries.
- Knowledge and experience with case-processing guidelines as per local and Global GVP requirements.
- Strong communication and narrative writing skills.
- Knowledge with US/Global safety reporting and regulatory compliance.
- Competent in Microsoft Word, PowerPoint, Excel.
- Strong attention to detail.
- Ability to work independently.
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 KRAS G12C 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 KRAS G12D 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.