Quality And Medical Reviewer

ProductLife Group is looking for Quality and Medical Reviewers, having 3+ years of ICSR processing (including principles of Medical Review).

Responsibilities:

• Quality Review and Medical review of the ICSRs (Spontaneous, literature, clinical studies) in post marketing drug safety.
• Performing Quality Check of Medical Review.
• Support in seriousness assessment, Initial Triage and review sample cases of closed ICSR cases in ABCube for accuracy and report findings.
• Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
• Perform additional review of cases to ensure competency.
• Participate in audits and inspections as required.
• Ensure understanding of client needs, conventions and ensure expectations are met and exceeded.

Required Education:

Required Experience:

• Experienced in European GVP Regulations, MedDRA coding, greater than 5 years PV experience.
• With 3+ years of ICSR processing (including principles of Medical Review).
• Prefer candidates with PV auditing or quality experience.
• Note: If the candidate has knowledge of Medical Review principles as a general PV auditor, they do not need to be an MD.
• If the candidates do not have this experience, then one of the candidates must be an MD with the ability to perform Medical Review and general case Quality review.
• Safety Database experience - ABCube.

Skills:

• Fluent in both English and French Language.
• Effective communication skills.
• Reliable.
• Organised.
• Punctual.
• Safety database experience.
• Previous experience performing triage and processing of post marketing cases.

Seniority level

Associate

Employment type

Temporary

Job function

Consulting, Quality Assurance, and Project Management.

Industries

Pharmaceutical Manufacturing.