Manager, Pharmacovigilance Operations

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts

 

Summary:

Reporting to the Director, Pharmacovigilance Operations, you will have a broad scope of responsibilities that includes participating in the oversight of the day-to-day operational ICSR activities of the vendor across multiple studies, tracking regulatory submissions to ensure compliance to regulatory timelines, and a highly visible role in representing PV operations in cross functional study teams and other key department initiatives.

Your role:

• Serve as the PV operations lead for the assigned studies and be responsible for managing and completing all PV deliverables for those studies
• Partner with the Tango regulatory operations team and be the primary point of contact for tracking all submissions of expedited reports, ensuring high compliance with regulatory timelines
• Be involved in analyzing safety data from an operations perspective to make sure that the PV processes are performed in a consistent and compliant manner across all Tango programs
• Participate in the review of study plans, including protocols, safety management plans, CRF completion guidelines, data validation manuals, and take part in the necessary UAT testing for EDC modifications
• Manage the review of PV documentation in the TMF, and report any findings to the TMF lead in Clinical Quality and Compliance
• Assist with monitoring internal drug safety mailbox, and triage communications with the appropriate colleagues to ensure timely action
• Participate in a routine assessment of vendor performance and apply your expertise/experience in making recommendations for improvement to any identified gaps
• You will be an integral part of a high-functioning PV Operations team and support any other ad-hoc projects as needed

What you bring:

• At least 3 – 5 years’ experience in PV Operations
• Bachelor’s degree in life sciences or nursing
• Experience with safety databases (ARGUS, ARISg, and/or Veeva) required
• Good knowledge of FDA and EMA regulations required
• Oncology experience is a plus but not required
• Familiarity with MedDRA coding desirable
• Critical thinking, proactive and keen attention to detail
• Be able to work well independently as well as a team player
• Strong work ethic and interpersonal communication
• Positive attitude and enthusiasm to adapt to changing timelines and deliverables

 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.