Pharmacoepidemiologist M/F

JR France; Laval; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Join a leading Contract Research Organization as a Pharmacoepidemiologist. Contribute to impactful clinical research by ensuring the scientific quality of studies and managing operational follow-ups. Ideal candidates will have a Master's degree or higher in relevant fields and at least 5 years of experience. The role offers opportunities for career development in a diverse and inclusive environment.

Prestations

Career Development

Diversity, Equality, and Inclusion

Qualifications

• At least 5 years of experience in a similar role.
• Ability to work transversally in multidisciplinary teams.

Responsabilités

• Ensure scientific quality of studies and manage operational follow-up.
• Analyze pharmacoepidemiological literature for safety signals.
• Write summaries for regulatory authorities.

Connaissances

Project Management

Listening Skills

Diplomacy

Fluent in English

Proficiency in French

Formation

Master's degree in Public Health

PhD in Epidemiology

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? Join Aixial Group and contribute to shaping the future of clinical research!

We are currently seeking a Pharmacoepidemiologist (M/F) to carry out 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 the operational follow-up of entrusted studies (management of service providers, 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 for regulatory authorities in a confidential context.
6. 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:

1. You hold a Master's degree (BAC+5), PhD, PharmD in public health, epidemiology, or an equivalent field.
2. You have at least 5 years of experience in a similar role.
3. You can manage projects and work transversally 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. Proficiency in French (professional or fluent level) 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 the life sciences industry.
4. Part of the ALTEN Group since 2014, we continuously explore new opportunities to expand our global presence.

Why join us?

1. Make a positive impact: Be part of groundbreaking clinical research that benefits millions worldwide.
2. Career development: We value our people and support their growth through coaching, mentoring, and fostering a positive environment.
3. Diversity, Equality, and Inclusion: We promote dignity and respect, valuing individual differences and ensuring gender equality.

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