Safety Medical Reviewer
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1791658
Job Description Summary
Mirati is looking for a Safety Medical Reviewer to join our growing team. This position is primarily responsible for performing medical review and assessment of serious adverse event reports that are processed. This involves checking for accuracy and completeness of ICSRs and ensuring accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding). Additional responsibilities include providing support for other investigational and marketed products. This includes pre- and post-marketing safety, Pharmacovigilance (PV) and preparing / supporting signal detection, aggregate safety reports (DSUR/PSUR) and risk management activities. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
- Perform medical review and assessment of serious adverse event (SAE) reports that are processed, checking for accuracy and completeness of ICSRs.
- Ensure accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding).
- Prepare Analysis of Similar Events (AOSE) summary for SUSARs requiring safety reporting.
- Perform signal detection activities including the searching of databases, literature, and other sources of data, preparing safety signal reports for safety evaluation, and performing ad hoc analyses as required
- Support or draft safety related documents (e.g. IB, DSUR, PSUR/PBRER and RMP) and safety responses regarding safety issues.
- Contribute to vendor oversight activities / interactions from a scientific / medical safety perspective and participate in inspection readiness activities and preparation as needed.
- Involved in internal process improvement activities such as SOPs or guidance documents as assigned.
- Under the direction/review of senior PV staff, participate in other PV and Safety Risk Management activities as necessary
What is Required
- Medical Doctor (MD), Doctor of Osteopathic Medicine (DO) or Nurse Practitioner (NP) with 2 years of experience in Drug Safety and PV
- Experience with drug safety databases (ARGUS experience a plus) and the responsibility for medical review of SAE reports
- Thorough knowledge of current US, Global, and ICH safety reporting regulations and guidelines
- Strong working knowledge of MedDRA and WHODrug coding dictionaries
- Excellent written and oral communication skills in the English language, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
- Competent in Microsoft Word, PowerPoint, Excel
- Ability to maintain an "inspection ready" environment
- Ability to work independently and strong attention to detail
- Solid medical knowledge of methods to assess causality relationship between adverse events and administration of investigational and marketed products
- Relevant experience in the oncology therapeutic area, strongly preferred
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.