Senior Manager, Pharmacovigilance Operations
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2132000
Job Description Summary
The Senior Manager, Pharmacovigilance Operations is responsible for the collection, triage, processing, review and submission of adverse drug reactions for Mirati's marketed products and the associated processes and procedures. This role serves as a subject matter expert for all case processing related enquiries, which includes working within the Mirati safety database to monitor workflow and collaborating with the Systems team to retrieve data for metrics and compliance. This position interacts with other functions including Commercial, Regulatory Affairs, Medical Affairs, Quality Assurance, and external consultants and contractors.
- Assist in the oversight of vendor activities for safety reporting including the collection, processing, and reporting/submission of safety information for all products
- Assist in the development of post-market pharmacovigilance procedures and conventions
- Assist with the management of vendor reconciliation for all post-marketing sources
- Conduct quality review of cases in the Mirati safety database and assist in compiling SLA metrics
- Support signal detection and risk management activities
- Assist in the procurement of metrics and validated outputs from the safety database
- Maintain pharmacovigilance related plans and documentation
- Represent PV Operations in external research activities such as investigator sponsored studies.
- Assist with the preparation of periodic safety reports (e.g., PADER/PBRER)
- Maintain inspection readiness and participate in health authority inspections and internal audits
- Assist in safety system projects including user acceptance testing, update of business process documents, and training of internal staff and vendors
- Review regulatory changes and perform impact assessments
- Assist in the investigation, remediation, and preventative actions for internal or external deviations
What is Required
- Bachelor's degree, health care related field (preferred)
- At least 5 years of experience in the pharmaceutical industry with at least 3 years in a drug safety/pharmacovigilance role at a global commercial organization
- Management of external PV service providers
- Thorough knowledge of current global pharmacovigilance 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.