Our client is looking to fill the role of 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.

Required Qualifications:

• 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.

If you meet the required qualifications and are interested in this role, please apply today. 

Clinical Resource Network Distinction  

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve. 

About CRN 

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn. 

Opportunity Awaits.