Pharmacoepidemiologist M / F

AIXIAL GROUP; Nantes; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Une entreprise leader en recherche clinique basée à Nantes recherche un pharmacovigiliste pour assurer la qualité scientifique des études et gérer leur suivi opérationnel. Le candidat idéal possède un Master (BAC+5) dans le domaine de la santé publique ou de l'épidémiologie avec au moins 5 ans d'expérience. Une bonne maîtrise de l'anglais et du français est souhaitée. Rejoignez une équipe dynamique et impactez positivement la recherche clinique.

Prestations

Développement de carrière

Engagement en matière de diversité et d'inclusion

Qualifications

• Au moins 5 ans d'expérience dans un poste similaire.
• Niveau professionnel ou courant en français est un plus.
• Maîtrise de l'anglais (écrit et oral).

Responsabilités

• Assurer la qualité scientifique des études confiées.
• Gérer le suivi opérationnel des études.
• Analyser la littérature scientifique pharmacoépidémiologique.

Connaissances

Gestion de projet

Compétences diplomatiques

Écoute active

Formation

Master (BAC+5), PhD, PharmD en santé publique, épidémiologie

Description du poste

Overview

You are a highly skilled professional with passion for the world of life sciences and clinical research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives? Come and join Aixial Group to contribute to shaping the future of clinical research!

We are currently looking for a Pharmacoepidemiologist M / F to carry out the following tasks (non-exhaustive list) :

Responsibilities

• Ensuring the scientific quality of entrusted studies (protocols, statistical analysis plans, study reports, result interpretation, study documents, project meetings)
• Ensuring the operational follow-up of entrusted studies (management of service providers, management of internal procedures related to studies)
• Managing the epidemiological evaluation of safety signals (review and analysis of scientific literature)
• Contributing to updates of crisis management plans, responses to health authority queries, and participation in cross-functional meetings (with pharmacovigilance, medical affairs, and regulatory affairs)
• Writing summaries in a confidential context towards regulatory authorities
• Carefully following operational procedures while respecting deadlines
• Analyzing pharmacoepidemiological scientific literature for safety signals / SER, RMP, PBRER / PSUR
• Reviewing protocols, statistical analysis plans, and study reports for PASS (Post-Authorisation Safety Study)
• Ensuring compliance with submission timelines of PASS study documents to regulatory authorities

Your profile

• You have a Master\'s degree ( BAC+5 ), PhD, PharmD with a specialization in public health, epidemiology, or equivalent field of study
• You have at least 5 years of experience in a similar position
• Ability to manage a project and work transversally in multidisciplinary teams : medical, regulatory, marketing, etc
• You have good listening skills and diplomacy
• You are fluent in English (written and spoken)
• You have a professional or fluent level in French would be a plus

Who Are we?

• We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.
• We work with global, pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.
• We are operating in 10 countries across 3 continents , bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.
• We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide.

Why Join Us ?

• Make a positive impact and be at the forefront of project : You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.
• Career Development : People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.
• Our commitment to Diversity, Equality, and Inclusion : We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. Gender equality is at the core of the development strategy of Aixial Group.

Aixial Group continues to grow, and to recruit in the clinical trial professions.

Join us, and discover our website to follow the news of our offers :

https :

// www.aixialgroup.com / join-us /