Associate Medical Director, Pharmacovigilance

tangotherapeutics; Boston (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Tango Therapeutics, a Boston-based biotechnology company, seeks a Medical Director/Medical Reviewer, Pharmacovigilance, to oversee medical review of Individual Case Safety Reports (ICSRs) and ensure accuracy, consistency, and regulatory compliance. The role involves medical oversight of vendor ICSR activities and escalation of significant safety information.

The candidate will perform medical review, assess cases for seriousness and causality, and contribute to the development of PV procedures

Qualifications

• 4+ years of total relevant experience in Pharmacovigilance/Drug Safety or Clinical Research.
• 2-5 years of hands-on ICSR medical review experience preferred.
• MD/DO/Foreign Medical Graduate or equivalent clinical/medical qualification.
• Working knowledge of ICH, GVP, FDA, EMA pharmacovigilance requirements.
• Experience reviewing AOSEs or other safety surveillance assessments is preferred.

Responsibilities

• Perform Medical Review activities and provide medical oversight of ICSRs.
• Review IC SRs for seriousness, causality, expectedness, and clinical significance.
• Evaluate case details for medical consistency including demographics, history, meds, labs, treatment, and outcomes.
• Review and validate MedDRA coding, diagnoses, events, indications, and relevant data.
• Assess temporal relationships, de-challenge/rechallenge, and potential alternative etiologies.
• Edit and approve ICSR narratives for accuracy, completeness and clarity.
• Provide medical assessment and rationale in company comments for ICSRs.
• Identify missing information and recommend follow-up queries.
• Escalate significant safety information to stakeholders and provide vendor guidance.
• Support PV procedures, medical review guidelines, and training materials.

Skills

ICSR medical review

Pharmacovigilance

Clinical research

Medical writing

Communication skills

Safety signal assessment

Education

MD/DO or foreign medical graduate

Tools

MedDRA terminology

Job description

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. Additionally, perform ad-hoc activities as assigned.

Your Role

• Perform Medical Review activities
• Review IC...
• 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 ICSR, 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.