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.
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Pharmacovigilance Specialist in Paris employeur : Excelya Group
Rejoignez Excelya, une entreprise jeune et ambitieuse qui allie passion pour la science et enthousiasme du travail d'équipe. En tant que Project Manager Clinical Systems, vous bénéficierez d'un environnement inclusif qui favorise la collaboration et la croissance individuelle, tout en participant à des projets divers et stimulants au sein d'une entreprise en pleine expansion dans le secteur de la santé. Nous valorisons vos talents naturels et encourageons l'audace, vous permettant ainsi de contribuer pleinement à notre mission commune d'amélioration du parcours patient.
