Global Pharmacovigilance Medical Review Specialist

Excelya; Paris; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Excelya is seeking a Medical Reviewer to perform the medical review and assessment of pharmacovigilance cases, ensuring accurate data extraction from source documents. You will collaborate with PV Operations to support case processing and ensure compliance with regulations.

The role requires a Master's degree in Life Sciences or Pharmacy, strong analytical skills, and excellent English communication. Experience in PV and SDDA is a plus, and the position offers opportunities for growth within a

Qualifikationen

• Master's degree in Life Sciences, Pharmacy, or a related field.
• Experience in Pharmacovigilance and Safety Data Exchange Agreements is a plus.
• Strong ability to review, interpret and analyze medical records and source documentation.
• Experience handling complex or medically significant safety cases is highly desirable.

Aufgaben

• Perform the medical review and assessment of sensitive and complex pharmacovigilance cases based on source documents and medical records.
• Analyze case documentation to identify, extract and evaluate relevant medical information in accordance with applicable procedures and guidelines.
• Contribute to the medical and scientific evaluation of safety cases, ensuring the completeness, consistency and accuracy of collected data.
• Collaborate closely with Pharmacovigilance Operations teams to support case processing activities.
• Review documentation to identify potential duplicate cases and support their assessment in collaboration with PV teams.
• Identify potential adverse events and ensure their timely communication for entry into the global pharmacovigilance database.
• Assess and communicate significant new safety information and follow-up data arising from additional source documentation.
• Ensure compliance with pharmacovigilance regulations, internal procedures and quality standards.
• Support continuous improvement initiatives related to medical case review and pharmacovigilance processes.

Kenntnisse

Analytical skills

Attention to detail

Communication skills

Cross-functional collaboration

Ausbildung

Master's degree in Life Sciences or Pharmacy

Jobbeschreibung

Excelya is seeking a Medical Reviewer to perform the medical review and assessment of pharmacovigilance cases, ensuring accurate data extraction from source documents. You will collaborate with PV Operations to support case processing and ensure compliance with regulations.

The role requires a Master's degree in Life Sciences or Pharmacy, strong analytical skills, and excellent English communication. Experience in PV and SDDA is a plus, and the position offers opportunities for growth within a