Associate Medical Director, Pharmacovigilance
Want this job? Aria tailors your résumé to this role and submits the application on the employer's own platform — on your behalf. Free to start.
About this role
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
The Medical Director/Medical Reviewer, Pharmacovigilance will be responsible to perform medical review and assessment of Individual Case Safety Reports (ICSRs) and provide medical oversight. The Medical Reviewer will ensure clinical accuracy, consistency, quality, and compliance with applicable pharmacovigilance requirements.
Your Role
Perform Medical Review activities
• Review ICSRs from clinical trials, literature, solicited programs, and other sources
• Assess adverse events for seriousness, causality, expectedness/listedness, and clinical significance per regulations and company procedures
• Evaluate case details for medical consistency, including demographics, history, medications, labs, treatment, course, and outcomes
• Review and validate MedDRA coding, diagnoses, events, indications, and relevant medical data
• Assess temporal relationships, de-challenge/rechallenge, alternative etiologies, risk factors, and outcomes, as applicable
• Review, edit, and approve ICSR narratives for accuracy, completeness, concision, and clinical coherence
• Author robust and medically sound company comments for ICSRs, clearly documenting the company's medical assessment, clinical rationale, causality considerations, relevant medical history, alternative etiologies, and overall safety evaluation, as applicable
• Review queries, identify key missing information, and recommend appropriate case follow-up queries
• Ensure proper documentation and escalation of significant safety information
• Review vendor-created AOSEs/AOSE search terms for medical accuracy, completeness, consistency, and appropriateness
• Esca
Stop filling out applications one by one.