Pharmacoepidemiologist M/F

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

Résumé du poste

Join a leading Contract Research Organization as a Pharmacoepidemiologist. Contribute to impactful clinical research, ensuring scientific quality and managing safety evaluations. Ideal candidates have a Master's degree or higher and extensive experience in public health or epidemiology.

Prestations

Career Development

Diversity, Equality, and Inclusion

Qualifications

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

Responsabilités

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

Connaissances

Project Management

Listening Skills

Diplomacy

Epidemiology

Public Health

English

French

Formation

Master's degree

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

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

1. Ensuring scientific quality of studies (protocols, statistical analysis plans, reports, result interpretation, documentation, meetings)
2. Operational follow-up of studies (management of service providers and internal procedures)
3. Managing 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 affairs, and regulatory affairs
5. Writing summaries for regulatory authorities in a confidential context
6. Following operational procedures carefully while respecting deadlines
7. Analyzing pharmacoepidemiological literature related to safety signals, SER, RMP, PBRER/PSUR
8. Reviewing protocols, 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. Master's degree (BAC+5), PhD, PharmD or equivalent in public health, epidemiology, or related fields
2. At least 5 years of experience in a similar role
3. Ability to manage projects and work across multidisciplinary teams (medical, regulatory, marketing, etc.)
4. Good listening skills and diplomacy
5. Fluent in English (written and spoken)
6. Professional or fluent level in French is a plus

About Us:

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 companies, and more, providing innovative, scalable solutions.
3. Operating in 10 countries across 3 continents with over 1000 professionals dedicated to making a positive impact in life sciences.
4. Part of ALTEN Group since 2014, continuously expanding our global presence.

Why Join Us?

1. Make a positive impact by being part of groundbreaking clinical research that benefits millions worldwide.
2. Career Development: We value our people and foster an environment of growth, flexibility, and teamwork, providing coaching and mentorship.
3. Diversity, Equality, and Inclusion: We promote dignity, respect, and value individual differences, with gender equality at our core.

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