Manager, Pharmacovigilance Submissions
Employment Type: Full Time
Reference Number: 2561259
Job Description Summary
The Manager, Pharmacovigilance (PV) Submissions will be responsible for oversight of pre-marketing safety submissions, vendor management and support for compliance activities.
- Manage 7-day/ 15-day expedited periodic report distribution to cross-functional teams, clinical research organizations (CROs), business partners and investigator-sponsored trials (ISTs).
- Track and maintain compliance with regulatory timelines and submission requirements.
- Reconcile ICSR submissions with submission CROs and business partners.
- Monitor the safety database for failed submissions.
- Assess the impacts of changes in regulations on the safety database reporting rules and participate in user acceptance testing of rule updates.
- Manage the reference safety information tracking process for marketed products used in clinical trials.
- Work closely with the case processing and medical review teams to achieve submission timelines.
- Oversee the Submissions Mailbox.
- Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (DSURs, PADERs, etc.).
- Manage deviations for late case investigation ensuring resolution and implementation of corrective action(s) as required. Collaborate with PV Quality and Compliance for input and closure of deviations and CAPA.
- Review submissions compliance metrics and trends on a periodic basis.
- Perform eTMF reviews for safety submissions.
- Archive submissions specific documentation in the Mirati electronic document management system.
- Develop/maintain Work Instructions (WI) and Safety Reporting Plans (SRP).
- Support PV audits/inspections as needed. Responsible for organizing and tracking safety information requests and ICSR related health authority responses.
- Under the direction/review of senior PV staff, participate in other PV and Safety Risk Management activities, as needed.
What is Required
- Bachelor of Science Degree in life sciences/pharmacy/nursing or related field required.
- Worked with a drug safety database (ARGUS experience helpful) and have had minimum 3-4 years experience in pre-marketing global submissions.
- Worked prior in pre-marketing safety operations.
- Thorough knowledge of current US, Global, and ICH safety reporting regulations and guidelines.
- Relevant experience in the oncology therapeutic area, strongly preferred.
- Management of vendors and interactions with other third party clinical trial collaborators.
- Strong communication skills, to facilitate interactions with study teams and vendors.
- Competent in Microsoft Word, PowerPoint, Excel.
- Strong attention to detail.
- Ability to work independently.
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.