Associate Medical Director, Pharmacovigilance

Tango Therapeutics•Boston, MA

2d•Onsite

About The Position

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.

Requirements

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

Responsibilities

Perform Medical Review activities
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, 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, 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