Medical Case Review Physician

Pay Range: $140/hr–$150/hr. Remote opportunity, 4–6+ month contract.

Responsibilities

• Perform medical review and evaluation of individual case safety reports (ICSRs) for both investigational and marketed products, including assessment of seriousness, causality, expectedness, reportability, and determination of appropriate follow-up activities.
• Provide medical and scientific expertise to support the EU Qualified Person for Pharmacovigilance (QPPV) and the Head of Pharmacovigilance.
• Contribute to signal detection, signal assessment, and benefit-risk evaluation activities across the product portfolio.
• Provide medical input into aggregate safety reports, including PSURs/PBRERs, DSURs, and other regulatory safety submissions.
• Support the development, maintenance, and periodic updates of Risk Management Plans (RMPs).
• Review and provide medical oversight of safety-related documentation, including protocols, study reports, and pharmacovigilance procedures.
• Contribute to the preparation of responses to inquiries from global Health Authorities, including the FDA, EMA, MHRA, PMDA, and other regulatory agencies.
• Monitor emerging pharmacovigilance regulations, guidance, and industry best practices, ensuring continued organizational compliance through the implementation of updated processes and procedures.
• Ensure adherence to global pharmacovigilance regulations, industry standards, and internal policies governing drug safety activities.
• Participate in internal audits, regulatory inspections, and corrective and preventive action (CAPA) activities as required.
• Collaborate effectively with cross-functional stakeholders, including Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance.
• Perform additional responsibilities and special projects as assigned by the Head of Medical Safety.

Requirements

• MD, DO, or equivalent medical degree required.
• Board certification and/or completion of residency training in a relevant clinical specialty is strongly preferred.
• Strong clinical foundation with direct patient care experience and formal medical residency training.
• Minimum of 3 years of pharmacovigilance and drug safety experience within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
• Demonstrated expertise in medical review of ICSRs, including assessment of causality, seriousness, expectedness, and regulatory reportability in accordance with global pharmacovigilance requirements.
• Hands-on experience with safety databases; Argus Safety experience preferred.
• Familiarity with MedDRA coding principles and conventions.
• Experience supporting signal detection, aggregate reporting, benefit-risk assessments, risk management activities, and safety surveillance programs.
• Proven ability to contribute to regulatory submissions and Health Authority interactions related to drug safety and pharmacovigilance matters.
• Strong knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, and CIOMS requirements.
• Understanding of clinical development processes and applicable GCP and ICH guidelines.
• Excellent analytical, medical writing, communication, and presentation skills.
• Ability to work independently, exercise sound medical judgment, and thrive in a collaborative global matrix environment.
• Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines in a fast-paced setting.
• Demonstrated commitment to quality, compliance, and continuous improvement.

Preferred Attributes

• Experience supporting both clinical development and post-marketing safety activities.
• Experience working within global pharmacovigilance systems and cross-functional international teams.
• Ability to interpret complex safety data and effectively communicate medical risk-benefit assessments to diverse stakeholders.

Benefits

• Medical, dental, and vision coverage.
• 401(k) retirement plan.
• Telehealth services.
• Employee Stock Ownership Plan (ESOP).
• Commuter benefits.