SummaryThe 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. Additionally, perform ad-hoc activities as assigned.
Your RolePerform 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
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
