Associate Director, Pharmacovigilance Quality & Compliance
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1815971
Job Description Summary
The Associate Director, Pharmacovigilance Quality & Compliance will be responsible for the establishment and oversight of all quality aspects of the global Pharmacovigilance and Safety Risk Management organization through development and execution of global processes, standards, and compliance monitoring systems. Delivers PV training to Mirati personnel, vendors, and business partners. Provides leadership for pharmacovigilance compliance and continuous improvement.
Strategic direction and compliance oversight of the PV system.
Development and delivery of internal and external PV-related training, including setting training requirements, and overseeing training compliance for PV&SRM.
Preparation of Key Quality Indicators (KQIs) and Compliance Metrics.
Development and Management of the Pharmacovigilance System Master File (PSMF) as required globally.
Management of safety agreement (SDEA/PVA) processes, templates and systems and oversee quality assurance activities related to safety agreement implementation in partnership with business process owners and appropriate stakeholders.
Setting standards (e.g. development of SOPs, Policies, etc.) for worldwide PV practices.
Inspection Readiness within PV&SRM.
Management and support of regulatory authority inspections and internal audits of PV&SRM, business and co-development partners, local affiliate offices, and external service providers.
Process improvements and best practices for compliance and effectiveness.
Testing of the PV&SRM Business Continuity Plan (BCP).
What is Required
Minimum Bachelor's degree required preferably in healthcare or life sciences
Minimum of 8 years relevant industry experience, which includes at least 5 years of pharmacovigilance and compliance experience, global setting preferred.
Thorough knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA and ICH guidelines
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 KRAS G12C 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 KRAS G12D 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.