Pharmacoepidemiologist M/F

JR France; Versailles; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Join a leading global CRO as a Pharmacoepidemiologist, where you will ensure scientific quality and oversee studies in a dynamic, collaborative environment. Contribute to impactful clinical research and manage projects within multidisciplinary teams. We value diversity and support your career development.

Prestations

Career Development

Diversity, Equality, and Inclusion

Qualifications

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

Responsabilités

• Ensure scientific quality of studies and oversee operational follow-up.
• Manage epidemiological evaluation of safety signals and write summaries for regulatory authorities.
• Analyze pharmacoepidemiological literature for safety signals.

Connaissances

Project Management

Listening Skills

Diplomacy

Epidemiology

Public Health

Fluent English

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 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):

1. Ensure scientific quality of studies (protocols, statistical analysis plans, study reports, result interpretation, study documents, project meetings).
2. Oversee operational follow-up of studies (manage service providers, internal procedures related to studies).
3. Manage epidemiological evaluation of safety signals (literature review and analysis).
4. Contribute to updates of crisis management plans, respond to health authority queries, and participate in cross-functional meetings (with pharmacovigilance, medical affairs, regulatory affairs).
5. Write summaries for regulatory authorities in a confidential context.
6. Follow operational procedures carefully while respecting deadlines.
7. Analyze pharmacoepidemiological literature for safety signals/SER, RMP, PBRER/PSUR.
8. Review protocols, statistical analysis plans, and study reports for PASS (Post-Authorization Safety Study).
9. Ensure timely submission of PASS study documents to regulatory authorities.

Your profile:

1. Master's degree (BAC+5), PhD, PharmD in public health, epidemiology, or equivalent.
2. At least 5 years of experience in a similar role.
3. Ability to manage projects and work transversally in multidisciplinary teams.
4. Good listening skills and diplomacy.
5. Fluent in English (written and spoken).
6. Professional or fluent level in French is a plus.

Who Are We?

• We are a global leader in CRO (Contract Research Organization), committed to delivering efficient clinical trials with expertise and flexibility.
• We collaborate with pharmaceutical, biotech, cosmetic, medical device, and other companies worldwide, providing innovative solutions.
• We operate in 10 countries across 3 continents, with over 1000 talented professionals.
• Part of ALTEN Group since 2014, we continuously seek new opportunities to expand globally.

Why Join Us?

• Make a positive impact: Be part of groundbreaking clinical research that benefits millions worldwide.
• Career Development: We support your growth through coaching, mentoring, and a supportive environment fostering teamwork and flexibility.
• 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 follow our news and offers on our website.