Pharmacovigilance Case Reviewer & Safety Analyst

Excelya; Paris; On-site; EUR 60,000 - 90,000; Full time

Job summary

Excelya in Paris is seeking a skilled Pharmacovigilance Medical Reviewer to assess and review complex safety cases from source documents and medical records. You will evaluate clinical information, identify key data, and contribute to the medical and scientific evaluation of safety cases.

You will collaborate with PV Operations teams to support case processing, ensure compliance with regulations, and help drive continuous improvement in medical review processes within a global, cross-functional

Qualifications

• Master's degree in Life Sciences, Pharmacy, or related field.
• PV experience and Safety Data Exchange Agreements a plus.
• Strong ability to review and analyze medical records.
• Understanding of PV principles and adverse event reporting.
• Experience handling complex safety cases is desirable.
• Strong analytical skills and attention to detail.
• Ability to synthesize large volumes of medical information.
• Experience in global and cross-functional environments.
• Excellent written and verbal English.

Responsibilities

• Perform medical review and assessment of pharmacovigilance cases based on source documents and medical records.
• Analyze case documentation to extract and evaluate relevant medical information.
• Contribute to medical and scientific evaluation of safety cases for completeness and accuracy.
• Collaborate with PV Operations teams to support case processing activities.
• Review documentation to identify potential duplicate cases and support assessment with PV teams.
• Identify potential adverse events and communicate for entry into global PV database.
• Assess and communicate new safety information and follow-up data.
• Ensure compliance with pharmacovigilance regulations and quality standards.
• Support continuous improvement initiatives related to medical case review.

Skills

Pharmacovigilance

Medical review of cases

Data extraction

Medical records analysis

Regulatory compliance PV

Communication skills

Cross-functional collaboration

English proficiency

Education

Master's degree in Life Sciences/Pharmacy or related field

Tools

Argus Safety

MedDRA

Job description

Excelya in Paris is seeking a skilled Pharmacovigilance Medical Reviewer to assess and review complex safety cases from source documents and medical records. You will evaluate clinical information, identify key data, and contribute to the medical and scientific evaluation of safety cases.

You will collaborate with PV Operations teams to support case processing, ensure compliance with regulations, and help drive continuous improvement in medical review processes within a global, cross-functional