Pharmacovigilance Specialist

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

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's leading mid-size CRO with the best employee experience .

Our one-stop provider service model offering 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.