Pharmacovigilance Specialist

Excelya Group; Paris; On-site; EUR 65,000 - 90,000; Full time

Job summary

Excelya is seeking a PV Medical Reviewer to perform medical review and assessment of pharmacovigilance cases based on source documents and medical records. You will analyze case documentation to extract and evaluate relevant medical information and contribute to safety data evaluations in a global context.

The role requires a Master's in Life Sciences or Pharmacy, strong understanding of PV principles, and excellent written and verbal English.

Qualifications

• 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.
• Good understanding of pharmacovigilance principles, adverse event reporting requirements and case management processes.
• Experience handling complex or medically significant safety cases is highly desirable.
• Strong analytical skills with excellent attention to detail.
• Ability to assess and synthesize large volumes of medical information.
• Experience working within global and cross-functional environments.
• Excellent written and verbal communication skills in English.

Responsibilities

• 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.

Skills

Pharmacovigilance

Medical review

Data extraction

Analytical skills

English proficiency

Cross-functional collaboration

Education

Master's degree in Life Sciences or Pharmacy

Experience with Safety Data Exchange Agreements

Job description

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Key responsabilities:

• 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.

Profile:

• 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.
• Good understanding of pharmacovigilance principles, adverse event reporting requirements and case management processes.
• Experience handling complex or medically significant safety cases is highly desirable.
• Strong analytical skills with excellent attention to detail.
• Ability to assess and synthesize large volumes of medical information.
• Experience working within global and cross-functional environments.
• Excellent written and verbal communication skills in English.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service modeloffering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care

means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.