Pharmacoepidemiologist M/F

JR France; Niort; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A leading Contract Research Organisation is looking for a skilled Pharmacoepidemiologist to ensure the scientific quality of studies and manage safety evaluations. Join a dynamic team dedicated to impactful clinical research. Opportunities for career development and a collaborative work environment await you.

Prestations

Career development opportunities

Diversity and inclusion initiatives

Qualifications

• At least 5 years of experience in a similar position.
• Fluent in English, professional level in French is a plus.

Responsabilités

• Ensure scientific quality of studies and operational follow-up.
• Manage epidemiological evaluation of safety signals.
• Write summaries for regulatory authorities.

Connaissances

project management

listening skills

diplomacy

Formation

Master's degree

PhD

PharmD

Description du poste

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You are a highly skilled professional with a 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's 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):

1. Ensuring the scientific quality of entrusted studies (protocols, statistical analysis plans, study reports, result interpretation, study documents, project meetings)
2. Ensuring the operational follow-up of entrusted studies (management of service providers, management of internal procedures related to studies)
3. Managing the epidemiological evaluation of safety signals (review and analysis of scientific literature)
4. 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)
5. Writing summaries in a confidential context towards regulatory authorities
6. Carefully following operational procedures while respecting deadlines
7. Analyzing pharmacoepidemiological scientific literature for safety signals/SER, RMP, PBRER/PSUR
8. Reviewing protocols, statistical analysis plans, and study reports for PASS (Post-Authorisation Safety Study)
9. 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 an equivalent field of study
• You have at least 5 years of experience in a similar position
• You have the ability to manage a project and work transversally in multidisciplinary teams: medical, regulatory, marketing, etc.
• You possess 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 other companies worldwide, providing innovative and scalable solutions.
• We operate in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to making 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 projects: You will be part of groundbreaking advancements in clinical research that positively impact millions of lives globally.
• Career development: People are our biggest asset. We are committed to empowering our team and fostering a positive, flexible, and collaborative environment. At Aixial Group, you will be coached and mentored throughout your journey to support your professional and personal growth.
• Our commitment to diversity, equality, and inclusion: We aim to create a workforce that promotes dignity and respect, recognizes individual differences, and allows each employee to give their best. Gender equality is central to Aixial Group's development strategy.

Aixial Group continues to grow and recruit in the clinical trial professions. Join us and visit our website to follow the latest news and offers.