Associate Medical Director, Pharmacovigilance

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

Escalate medically significant cases and potential safety concerns to appropriate stakeholders

Provide medical guidance to the vendor on findings and recurring quality issues

Monitor quality and consistency, identifying trends that require training or process improvement

Provide vendor guidance and feedback to maintain consistent ICSR quality

Support activities related to creation or maintenance of PV procedures, medical review guidelines, AOSE criteria, training materials, quality metrics and other relevant activities

Provide medical oversight of vendor-performed ICSR activities

Review vendor deliverables for quality, accuracy, completeness, and timeliness

Identify recurring medical review quality issues and share findings with the vendor

Support vendor training and clarify medical review expectations, as needed

Contribute to vendor performance monitoring and quality improvement

Complete other ad hoc activities as assigned

What You Bring

4+ years of total relevant experience in Pharmacovigilance/Drug Safety, Clinical Research, or a related area. 2–5 years of hands-on ICSR medical review experience is preferred

MD/DO/Foreign Medical Graduate or equivalent clinical/medical qualification

Relevant experience in Pharmacovigilance, Drug Safety, Clinical Research

Hands-on experience in ICSR medical review and case assessment

Experience reviewing AOSEs or other safety surveillance assessments is preferred

Good understanding of ICH, GVP, FDA, EMA, and applicable pharmacovigilance requirements

Working knowledge of WHO drug and MedDRA terminology and coding principles

Strong clinical assessment, analytical, medical writing, and communication skills

Ability to independently assess complex clinical cases and make sound medical judgments

Excellent communication and cross-functional collaboration skills

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.

Salary range

$194,400 — $291,600 USD