Associate Medical Director, Pharmacovigilance
Tango Therapeutics
August 21, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
Summary / Responsibilities:
- Perform medical review and assessment of Individual Case Safety Reports (ICSRs) and provide medical oversight.
- 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 (demographics, history, medications, labs, treatment, course, 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.
- Review, edit, and approve ICSR narratives for accuracy, completeness, concision, and clinical coherence.
- Author medically sound company comments for ICSRs, including medical assessment, rationale, causality considerations, alternative etiologies, and overall safety evaluation.
- Review queries, identify missing information, and recommend 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 safety concerns; provide medical guidance, monitor quality/trends, review vendor deliverables, and support PV procedure/guideline/training/quality metric activities.
Qualifications / What You Bring:
- 4+ years relevant experience in Pharmacovigilance/Drug Safety, Clinical Research, or related area; 2–5 years hands-on ICSR medical review preferred.
- MD/DO/Foreign Medical Graduate or equivalent clinical/medical qualification.
- Relevant PV/Drug Safety/Clinical Research experience; hands-on ICSR review and case assessment.
- Experience reviewing AOSEs or other safety surveillance assessments preferred.
- Working knowledge of ICH, GVP, FDA, EMA, and pharmacovigilance requirements.
- Working knowledge of WHO drug and MedDRA terminology/coding principles.
- Strong clinical assessment, analytical, medical writing, and communication skills.
- Ability to independently assess complex cases and make sound medical judgments.
Salary range:
- $194,400—$291,600 USD.
- Perform medical review and assessment of Individual Case Safety Reports (ICSRs) and provide medical oversight.
- 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 (demographics, history, medications, labs, treatment, course, 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.
- Review, edit, and approve ICSR narratives for accuracy, completeness, concision, and clinical coherence.
- Author medically sound company comments for ICSRs, including medical assessment, rationale, causality considerations, alternative etiologies, and overall safety evaluation.
- Review queries, identify missing information, and recommend 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 safety concerns; provide medical guidance, monitor quality/trends, review vendor deliverables, and support PV procedure/guideline/training/quality metric activities.
Qualifications / What You Bring:
- 4+ years relevant experience in Pharmacovigilance/Drug Safety, Clinical Research, or related area; 2–5 years hands-on ICSR medical review preferred.
- MD/DO/Foreign Medical Graduate or equivalent clinical/medical qualification.
- Relevant PV/Drug Safety/Clinical Research experience; hands-on ICSR review and case assessment.
- Experience reviewing AOSEs or other safety surveillance assessments preferred.
- Working knowledge of ICH, GVP, FDA, EMA, and pharmacovigilance requirements.
- Working knowledge of WHO drug and MedDRA terminology/coding principles.
- Strong clinical assessment, analytical, medical writing, and communication skills.
- Ability to independently assess complex cases and make sound medical judgments.
Salary range:
- $194,400—$291,600 USD.