Director – Pharmacovigilance Operations
Posted on 9/5/2023
Tango Therapeutics

51-200 employees

Cambridge, MA, USA
Experience Level
Desired Skills
Operations & Logistics
  • At least 10 years relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 3+ years vendor oversight experience, required
  • Bachelor's Degree in a life-sciences; advanced degree preferred
  • Drug safety database (Argus or ARISg) experience required
  • Direct experience with Health Authority inspections preferred
  • Expert knowledge of global regulatory pharmacovigilance requirements and guidelines (e.g., ICH, FDA, GVP)
  • Solid understanding of pharmaceutical drug development process
  • Excellent verbal, written communication, and interpersonal skills
  • Proficiency in Microsoft Word, PowerPoint, and Excel
  • Good organizational skills and ability to work independently
  • You will serve as the primary pharmacovigilance lead on study teams and liaise with cross functional team members, as well as external vendors and services providers; performing drug safety study start-up, maintenance, and close-out activities
  • Participate in authoring, reviewing, and updating of clinical study documents such as: clinical protocols, informed consent forms, investigator brochures, clinical study reports, data management plans, reconciliation guidelines, and safety report forms
  • Manage the preparation, revision, and review of safety management plans
  • Responsible for pharmacovigilance vendor's day-to-day case intake, processing, and submission/exchange activities; ensuring high-quality reporting in the safety database and adherence to agreed processing timelines to support compliance in reporting submissions and exchange
  • Identify and escalate trends/issues in vendor performance based on routine oversight of vendor's activities, vendor-generated operational/compliance reports or metrics, and feedback from other functional stakeholders
  • Serve as a pharmacovigilance operations subject matter expert (SME) for inspections and audits, and support department/company inspection and audit readiness initiatives
  • Lead pharmacovigilance QA activities, including review and tracking of deviation reports, quality events, and corrective and preventative actions (CAPAs)
  • Ensure set-up and maintenance of pharmacovigilance document repositories and document sharing platforms; ensure timely document uploading, filing, and archival to support compliance and inspection readiness
  • Maintain the pharmacovigilance deliverables across the portfolio
  • Continued process improvement and system implementation related to drug safety signal detection and monitoring
  • Additional duties and responsibilities as required