Pharmacoepidemiologist M/F

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

Résumé du poste

Join a leading Contract Research Organization as a Pharmacoepidemiologist. You'll ensure the scientific quality of studies, manage operational follow-ups, and conduct epidemiological evaluations. This role offers career development and the chance to make a positive impact in clinical research.

Prestations

Career Development

Mentorship

Commitment to Diversity, Equality, and Inclusion

Qualifications

• At least 5 years of experience in a similar role.
• Specialization in public health, epidemiology, or related fields.

Responsabilités

• Ensuring scientific quality of studies and managing operational follow-up.
• Conducting epidemiological evaluation of safety signals.
• Writing summaries for regulatory authorities.

Connaissances

Project Management

Listening Skills

Diplomacy

Fluency in English

Fluency in French

Formation

Master's degree (BAC+5)

PhD

PharmD

Description du poste

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Join Aixial Group as a Pharmacoepidemiologist (M/F)

Are you a highly skilled professional passionate about life sciences and clinical research? Do you thrive in a dynamic, collaborative international environment where your expertise can directly impact people's lives? Come and join Aixial Group to help shape the future of clinical research!

We are seeking a Pharmacoepidemiologist (M/F) to perform the following responsibilities (non-exhaustive list):

1. Ensuring the scientific quality of entrusted studies (protocols, statistical analysis plans, study reports, result interpretation, study documents, project meetings).
2. Managing operational follow-up of studies (management of service providers, internal procedures related to studies).
3. Conducting epidemiological evaluation of safety signals (literature review and analysis).
4. Contributing to updates of crisis management plans, responding to health authority queries, and participating in cross-functional meetings (with pharmacovigilance, medical, and regulatory affairs).
5. Writing summaries for regulatory authorities in a confidential context.
6. Following operational procedures carefully 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-Authorization Safety Study).
9. Ensuring timely submission of PASS study documents to regulatory authorities.

Your profile:

1. You hold a Master's degree (BAC+5), PhD, PharmD, or equivalent, with specialization in public health, epidemiology, or related fields.
2. You have at least 5 years of experience in a similar role.
3. You can manage projects and work across disciplines in multidisciplinary teams: medical, regulatory, marketing, etc.
4. You possess good listening skills and diplomacy.
5. You are fluent in English (written and spoken).
6. Having a professional or fluent level in French is a plus.

Who are we?

1. We are one of the world’s leading CROs (Contract Research Organization), committed to delivering efficient clinical trials with expertise and flexibility.
2. We collaborate with global pharmaceutical, biotech, cosmetic, medical device, and other companies, providing innovative and scalable solutions.
3. We operate in 10 countries across 3 continents, with over 1000 talented professionals dedicated to making a positive impact in life sciences.
4. We have been part of the ALTEN Group since 2014 and are continuously exploring new opportunities worldwide.

Why join us?

1. Make a positive impact by being at the forefront of groundbreaking clinical research that benefits millions globally.
2. Career development: We invest in our people, fostering growth, flexibility, and teamwork. You will receive coaching and mentorship to advance professionally and personally.
3. Our commitment to Diversity, Equality, and Inclusion: We promote dignity, respect, and value individual differences, with gender equality central to our strategy.

Aixial Group continues to grow and recruit in clinical trial professions. Join us and visit our website for updates on our offers.