Director - Contract - Boston - REMOTE
Lead medical safety oversight with precision, compliance, and clinical expertise.
À±½·ÊÓƵ is seeking a Director, Medical Review to provide medical assessment and oversight of individual case safety reports (ICSRs) in alignment with applicable regulations and agreements.
Primary Responsibilities:
The successful candidate will be involved in ensuring quality, compliance, and readiness for inspections while supporting global development programs and marketed products. You will collaborate with cross-functional teams to deliver accurate medical narratives and analyses.
Skills & Requirements:
- Ability to critically analyze clinical information for both clinical trial and post-marketing cases.
- Expertise in medical review and familiarity with safety databases (e.g., Argus).
- Strong clinical acumen and experience in individual case reviews.
- Knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance.
- Effective verbal and written communication skills to articulate medical rationale and defend recommendations.
- Experience managing external vendors and collaborating with cross-functional teams.
- MD required; Board Certification preferred.
- Clinical experience and significant pharmacovigilance/drug safety expertise, including medical review of ICSRs.
The Director's responsibilities will be:
- Oversee CRO individual case medical reviewers under the guidance of the Lead Medical Reviewer.
- Review ICSRs, including narrative coding, labeling, causality assessments, and company comments.
- Provide medical advice and input on adverse event (AE) case management activities.
- Collaborate with pharmacovigilance teams, risk management leads, and clinical development leads to ensure cohesive and accurate medical narratives.
- Serve as a resource for medical review of assigned compounds.
- Manage and resolve issues effectively, escalating when necessary.
- Participate in the development and maintenance of relevant SOPs and working practices.
- Contribute to process improvement initiatives within pharmacovigilance.
- Support audits and health authority inspections as needed.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsenproclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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