Pharmacovigilance Medical Director – ICSR Oversight

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

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