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Director, Medical Review - 100% Remote

Alpha Business Solutions

Cambridge, MA(remote)

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JOB DETAILS
SKILLS
Alliance/Partner Management, Analysis Skills, Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Healthcare, Industry Standards, Mentoring, Onboarding, Patient Care, Pharmacovigilance, Product Marketing, Product Safety, Product Testing, Quality Management, Regulations, Regulatory Compliance, Regulatory Reports, Safety Compliance, Team Lead/Manager, Team Player, Time Management
LOCATION
Cambridge, MA
POSTED
2 days ago
Title: Director, Medical Review
Location: 100% Remote
Duration: 6+ Months (Possible extension)
 
We have an exciting opportunity for a Director, Medical Review position supporting Global Pharmacovigilance activities. The role focuses on medical assessment and oversight of Individual Case Safety Reports (ICSRs) for both investigational and marketed products across multiple therapeutic areas.
 
Key Responsibilities:
  • Lead and oversee medical review of ICSRs, including seriousness, expectedness, causality assessments, event confirmation, coding, and follow-up activities.
  • Ensure compliant and timely safety reporting to global regulatory authorities.
  • Collaborate with Safety Scientists, Global Safety Leads, and cross-functional Pharmacovigilance teams to evaluate product safety profiles.
  • Provide medical expertise on case assessments and support resolution of safety-related queries.
  • Maintain consistency, quality, and regulatory compliance in medical review processes.
  • Mentor and train junior team members and support onboarding initiatives.
  • Partner with internal stakeholders and alliance partners to establish industry-standard medical review practices.
 
Qualifications:
  • Medical Degree (MD or internationally recognized equivalent) required.
  • 10+ years of pharmaceutical or healthcare industry experience.
  • 5+ years of clinical patient-care experience following postgraduate training.
  • 5+ years of Pharmacovigilance experience with significant hands-on medical review of ICSRs.
  • Strong understanding of global safety regulations, signal management, and safety databases.
  • Excellent analytical, communication, and cross-functional collaboration skills.

About the Company

A

Alpha Business Solutions

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