Drug Safety Scientist
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1665996
Job Description Summary
Mirati is looking for a Drug Safety Scientist to join our growing team. This position is primarily responsible for performing and contributing to safety documents, including safety queries, RMP, DSUR, PSUR/ PBRER in support of regulatory and partner reporting requirements. The Drug Safety Scientist will work collaboratively with Pharmacovigilance and Safety Risk Management colleagues and other teams to conduct safety surveillance activities and provide scientific drug safety/PV expertise with a focus on the signal detection, evaluation and management of safety risks for assigned investigational and/or marketed products throughout the products' lifecycle(s). The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
- Active participation on drug safety and pharmacovigilance teams' activities including performing case series review and tabulated/line-listings data review for identifying and assessing safety signals and adequately documenting discussions, conclusions and decisions.
- Project manage signal detection activities including the searching of databases, literature, and other sources of data, preparing safety signal reports for drug safety evaluation, and performing ad hoc analyses as required
- Draft and author responses and safety documents including safety queries, RMP, DSUR, PSUR/ PBRER, IB and others upon request.
- Assist/contribute the risk management documents, including Risk Management Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.
- Participate in inspection readiness activities and preparation as needed
- Perform aggregate safety analysis and case level review, and author and coordinate the preparation of core safety deliverables
- Recognize potential issues and/or safety issues and escalate to the attention of the report owner, line manager.
- Attention to detail and ability to analyze data in broader context, ability to (re)prioritize work/tasks of oneself and others
- Draft and author Standard Operating Procedures (SOPs) and Work Practice Instructions.
- Other functionality and assignments as mandated by business need
What is Required
- Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree.
- Minimum 2 years of experience in drug safety science role in biotech or pharmaceutical industry.
- Competent knowledge of good pharmacovigilance practices, US and EU pharmacovigilance regulatory requirements.
- Knowledge and experience with safety signal detection and management, safety surveillance, labeling analyses, and ad hoc safety analyses
- Experience with development and authorship of aggregate reports (i.e., DSUR, PSUR), Risk Management Plans, and SOPs/working instructions
- Worked with a drug safety database (ARGUS) and strong working knowledge of MedDRA and WHO Drug coding dictionaries
- Excellent written and oral communication skills
- Competent in Microsoft Word, PowerPoint, Excel
- Ability to work independently and strong attention to detail
- 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.