Job Opportunity

Sr. Product Safety Specialist

Location: US
Department: PharmacoVigilance
Employment Type: Full Time
Reference Number: 2482086

Job Description Summary

The Sr. Product Safety Specialist will report to and support the post-marketing pharmacovigilance operations senior manager. In this role, the Sr. Product Safety Specialist will serve as a primary contact point for the external case processing vendor and other external sources. This role will also provide input to and oversight of case processing and submission activities for Mirati's marketed products.

Your Responsibilities

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.

  • Support the collection, processing, and/or reporting of safety information
  • Triage, manage, and reconcile the Mirati safety intake tool
  • Perform quality review of adverse event reports, including accurate coding of MedDRA terms and preparation of case narratives
  • Monitor case processing workflow through use of various monitoring reports
  • Review expedited reports for submission to regulatory authorities
  • Address case-processing related queries from vendors or internal stakeholders
  • Review, update and maintain data entry guidelines
  • Assist with literature surveillance activities including identification of individual case safety reports
  • Assist in late case investigation and root cause analysis
  • Support audit and regulatory inspections preparedness
  • Ability to identify trends, critical issues, gaps in processes and escalate them to management
  • Provide safety operations support to partners and vendors
  • Support preparation and submission of aggregate reports including PSURs and PADERs
  • Support signal detection and evaluation activities in accordance with SOPs and guidelines
  • Develop and maintain Pharmacovigilance SOPs/work instructions as required

What is Required

  • Bachelors' Degree or higher preferably in nursing, pharmacy or related health care field.
  • At least 5 years' experience in drug safety operations with at least 3 years in postmarketing safety operations.
  • Proficient in all aspects of case processing including follow-up activities.
  • Oncology experience is preferred.
  • Experience with a drug safety database (ARGUS, preferred).
  • Strong communication and narrative writing skills.
  • Knowledge of global postmarket safety regulations and guidelines
  • Competent in Microsoft Word, PowerPoint, Excel.
  • Strong attention to detail.
  • Excellent organizational skills.
  • Ability to work independently and within a team in a fast-paced environment.

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.

For more information about Mirati Therapeutics, visit us at or follow us on Twitter and LinkedIn. 

Why Join?

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 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.