Associate Director, Pharmacovigilance Operations
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1977288
Job Description Summary
Mirati is looking for an Associate Director, Pharmacovigilance Operations, to join or growing team and lead our postmarketing pharmacovigilance activities. Reporting to the Head of Safety Operations, this position will initially help to build out the pharmacovigilance team, onboard the case processing vendor, and prepare internal processes and procedures. Upon commercialization of our first medicine, this position will be accountable for postmarketing operations including case receipt and processing, expedited submissions, business partner distributions, and vendor oversight.
- Ensure that all safety information received from any source is processed and reported according to regulatory requirements and internal standards and conventions
- Assist in the development of the postmarket pharmacovigilance strategy, standards, and conventions
- Oversee ICSR collection, processing, reconciliation, and reporting
- Oversee case processing vendor activities
- Manage vendor reconciliation for all postmarketing sources
- Conduct peer quality review of cases in the Mirati safety database
- Support signal detection and risk management activities
- Prepare and update departmental postmarketing policies and procedures
- Support the preparation of periodic safety reports (e.g., PADER/PBRER)
- Maintain inspection readiness and participate in health authority inspections and internal audits
- Line management experience including the hiring and development of pharmacovigilance operations personnel
What is Required
- BS/BA degree or higher in a health-related field (e.g., BSN, PharmD) is preferred
- At least 8 years of experience in pharmacovigilance operations at a global biopharmaceutical company with at least 3 years of postmarketing experience is required
- Thorough knowledge of current US, Global, and ICH safety management and reporting regulations and guidelines
- At least 2 years of experience with Argus Safety (8.1.x or higher)
- Excellent written and oral communication skills
- Competent in Microsoft Word, PowerPoint, Excel
- Strong attention to detail
- Experience in the oncology therapeutic area is 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.