Associate Medical Director, Pharmacovigilance

Socket.dev; Boston (MA); On-site; USD 194,000 - 292,000; Full time

Job summary

Tango Therapeutics is seeking a Medical Director/Medical Reviewer, Pharmacovigilance to perform medical review and oversight of ICSRs, ensuring clinical accuracy, consistency, and compliance with pharmacovigilance requirements. The role involves reviewing ICSRS from trials, literature, and solicitations, assessing causality, seriousness, and data integrity, and authoring medical evaluations.

The incumbent will validate MedDRA coding, ensure timely escalation of safety concerns, and guide vendors

Qualifications

• MD/DO or FMG with relevant pharmacovigilance experience.
• Hands-on ICSR medical review experience preferred.
• Strong knowledge of ICH, GVP, FDA/EMA regulations.
• Familiarity with WHO MedDRA terminology and coding.

Responsibilities

• Perform Medical Review activities.
• Review ICSSR 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, documenting medical assessment and causality considerations.
• Review queries, identify missing information, and recommend follow-up queries.
• Ensure proper documentation and escalation of significant safety information.
• Review AOSEs/AOSE search terms for accuracy and completeness.
• Escalate medically significant cases to appropriate stakeholders.
• Provide medical guidance to the vendor on findings and recurring quality issues.
• Monitor quality and trends to identify training or process improvement needs.
• Provide vendor guidance to maintain consistent ICSR quality.
• Support PV procedures, medical review guidelines, training materials, quality metrics, and related 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.

Skills

Pharmacovigilance

ICSR medical review

Medical writing

Analytical thinking

Cross-functional collaboration

Education

MD/DO or Foreign Medical Graduate

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.

Your Role

Perform Medical Review activities

• Review ICSSR 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 ICSR's, 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