Associate Medical Director, Pharmacovigilance – Safety Strategy

Tango Therapeutics; Boston (MA); Sur place; USD 194 000 - 292 000; Plein temps

Résumé du poste

Tango Therapeutics, based in Boston, seeks an Associate Medical Director, Pharmacovigilance to lead medical review and oversight of Individual Case Safety Reports (ICSRs). You will ensure clinical accuracy, consistency, quality, and compliance with pharmacovigilance requirements.

Responsibilities include reviewing ICSRs, assessing events, validating coding, and editing narratives while providing guidance to the vendor and stakeholders. 4+ years PV experience and MD/DO qualifications are required.

Qualifications

• 4+ years total experience in Pharmacovigilance/Drug Safety or related areas.
• 2-5 years hands-on ICSR medical review experience preferred.
• MD/DO/Foreign Medical Graduate or equivalent clinical/medical qualification.
• Experience reviewing AOSEs or other safety surveillance assessments preferred.
• Good understanding of ICH, GVP, FDA, EMA pharmacovigilance requirements.
• Strong medical writing and communication skills.

Responsabilités

• Perform Medical Review activities.
• Review ICSR and assess adverse events for seriousness, causality, expectedness, and clinical significance.
• Evaluate case details for medical consistency (demographics, history, medications, labs, treatment, outcome).
• Review and validate MedDRA coding, diagnoses, events, indications, and data.
• Assess temporal relationships, de-challenge/rechallenge, alternative etiologies, risk factors, and outcomes.
• Review, edit, and approve ICSR narratives for accuracy and coherence.
• Author robust and medically sound company comments for ICSR.
• Escalate medically significant cases and provide vendor guidance on findings.

Connaissances

Pharmacovigilance

ICSR medical review

Medical writing

Clinical assessment

Cross-functional collaboration

Formation

MD/DO/Foreign Medical Graduate

Description du poste

Tango Therapeutics, based in Boston, seeks an Associate Medical Director, Pharmacovigilance to lead medical review and oversight of Individual Case Safety Reports (ICSRs). You will ensure clinical accuracy, consistency, quality, and compliance with pharmacovigilance requirements.

Responsibilities include reviewing ICSRs, assessing events, validating coding, and editing narratives while providing guidance to the vendor and stakeholders. 4+ years PV experience and MD/DO qualifications are required.