Safety Medical Reviewer Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

 

ClinChoice is searching for a Safety Medical Reviewer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

 

Main Job Tasks and Responsibilities:

• Identify, review and evaluate individual case safety reports (ICSRs) including SAEs and SUSARs for completeness, accuracy, consistency, and overall medical content.
• Perform medical review of adverse event reports (SAEs and SUSARs), including expectedness/listedness, seriousness, and causality assessments.
• Ensure timely completion of medical reviews and assessment to meet internal and regulatory requirements.
• Prepare and draft case queries based on medical review of ICSRs, as appropriate. Track follow-up requests and interactions with healthcare professionals, investigators, or other stakeholders regarding adverse event information.
• Provide support and review for medical coding issues/discrepancies.
• Review of Line Listing of cases to evaluate the MedDRA coding and other applicable coding system as necessary.
• Escalates in a timely manner any potential safety issues or signals to the appropriate stakeholders.
• Develop and provide training related to medical review (ICSR, Aggregate Reports, or Signal Detection) for new hires and junior team members. Keep team’s knowledge up-to-date, based on the latest regulations and company conventions related to medical reviews.
• Based on requirement, may support in medical and scientific discussions with internal and external stakeholders.
• Collaborate with aggregate report medical writer and  physicians to write and review RMPs, aggregate reports (PSURs/PBRERs/PADERs/DSURs, IND Annual Reports, and other ad-hoc reports).
• Review and provide safety therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents, as assigned.
• Generate, review, and update follow-up queries for the prescribers and investigators, as assigned.
• Support signal detection activities by providing medical insights and identifying potential trends in safety data.
• Assist in writing and/or reviewing of monthly safety signal reports.
• Provide expert input on adverse event reports for regulatory and safety reporting.
• Participate in risk management and mitigation strategies in collaboration with safety and medical teams.
• Participate and support in internal and regulatory audit and inspections, as required.
• Work closely with the safety team, regulatory affairs, clinical development, and medical affairs to ensure alignment of safety data and compliance with regulatory guidelines.
• Provide medical expertise to help resolve complex safety issues or cases that require further clarification or follow-up.

 

 

Education and Experience:

 

• Medical Doctor, MD
• Excellent medical judgment and ability to assess causality and seriousness of adverse events.
• Attention to detail and accuracy in data review and reporting.
• Strong communication and collaboration skills for working with cross-functional teams.
• Ability to work in a fast-paced environment and manage multiple tasks with deadlines.

 

 

Specific Role Requirements and Skills:

 

• Strong understanding of safety regulations and guidelines (e.g., ICH, FDA, EMA).
• Experience in medical review for ICSRs and Signal Detection activities.
• Proficiency in MS Office and safety databases (e.g., Argus, Veeva Vault).

 

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the