Associate Medical Director, Pharmacovigilance

Company OverviewTango 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.SummaryThe 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 RolePerform Medical Review activities Review ICSRs from clinical trials, literature, solicited programs, and other sourcesAssess adverse events for seriousness, causality, expectedness/listedness, and clinical significance per regulations and company proceduresEvaluate case details for medical consistency, including demographics, history, medications, labs, treatment, course, and outcomesReview and validate MedDRA coding, diagnoses, events, indications, and relevant medical dataAssess temporal relationships, de-challenge/rechallenge, alternative etiologies, risk factors, and outcomes, as applicableReview, edit, and approve ICSR narratives for accuracy, completeness, concision, and clinical coherenceAuthor 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 applicableReview queries, identify key missing information, and recommend appropriate case follow-up queriesEnsure proper documentation and escalation of significant safety informationReview vendor-created AOSEs/AOSE search terms for medical accuracy, completeness, consistency, and appropriatenessEscalate medically significant cases and potential safety concerns to appropriate stakeholdersProvide medical guidance to the vendor on findings and recurring quality issuesMonitor quality and consistency, identifying trends that require training or process improvementProvide vendor guidance and feedback to maintain consistent ICSR qualitySupport activities related to creation or maintenance of PV procedures, medical review guidelines, AOSE criteria, training materials, quality metrics and other relevant activitiesProvide medical oversight of vendor-performed ICSR activitiesReview vendor deliverables for quality, accuracy, completeness, and timelinessIdentify recurring medical review quality issues and share findings with the vendorSupport vendor training and clarify medical review expectations, as neededContribute to vendor performance monitoring and quality improvementComplete other ad hoc activities as assignedWhat You Bring4+ 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 preferredMD/DO/Foreign Medical Graduate or equivalent clinical/medical qualificationRelevant experience in Pharmacovigilance, Drug Safety, Clinical ResearchHands-on experience in ICSR medical review and case assessmentExperience reviewing AOSEs or other safety surveillance assessments is preferredGood understanding of ICH, GVP, FDA, EMA, and applicable pharmacovigilance requirementsWorking knowledge of WHO drug and MedDRA terminology and coding principlesStrong clinical assessment, analytical, medical writing, and communication skillsAbility to independently assess complex clinical cases and make sound medical judgmentsExcellent communication and cross-functional collaboration skillsWe 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