Job Opportunity

Manager, Pharmacovigilance Operations

Location: US
Department: PharmacoVigilance
Employment Type: Full Time
Reference Number: 2487738

Job Description Summary

The Pharmacovigilance (PV) Manager will be responsible for oversight of pre-marketing safety operations, safety vendor management, assistance with SAE reconciliation, annual report preparation, and support for compliance activities.

Your Responsibilities

  • Oversight of SAE collection, processing, and distribution within established time frames and in compliance with global regulatory requirements.
  • Support development and maintenance of data entry guidelines and other PV operations specific documents.
  • Maintenance of PV SOPs and Work Instructions, working with Mirati Quality Assurance.
  • Oversight of vendors to maintain compliance, develop metrics and KPIs as needed. Create and maintain workflow trackers, flow charts as needed.
  • Support management of pharmacovigilance issues, deviations and CAPA development.
  • Coordinate with safety systems teams for safety database updates as necessary.
  • Support preparation and execution of safety data exchange agreements with licensing partners.
  • Support preparation and distribution of IND Annual Reports/Development Safety Update Reports (DSURs).
  • Represent PV and Safety Department as applicable.
  • Under the direction/review of senior PV staff, participate in other PV and Risk Management activities as necessary.

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 managing teams.
  • 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.
  • Relevant experience in the oncology therapeutic area, strongly preferred.
  • Management of CROs and interactions with other third party clinical trial collaborators.

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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn. 

Why Join?

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.