Pharmacoepidemiologist M/F

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

Résumé du poste

Join a leading global CRO as a Pharmacoepidemiologist, where you will ensure the scientific quality of studies and manage operational follow-up. With a focus on global health, you will work in a collaborative environment, contributing to impactful clinical research. This role offers career development opportunities and values diversity and inclusion.

Prestations

Career development opportunities

Commitment to diversity and inclusion

Qualifications

• At least 5 years of experience in a similar role.
• Fluent in English; French skills are a plus.

Responsabilités

• Ensure scientific quality of studies and manage operational follow-up.
• Evaluate safety signals epidemiologically and draft summaries for regulatory authorities.

Connaissances

Project management

Listening

Diplomacy

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 impact lives? Join Aixial Group and help shape the future of clinical research!

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

1. Ensure the scientific quality of studies (protocols, statistical analysis plans, reports, interpretation, documents, meetings).
2. Manage operational follow-up of studies (service providers, internal procedures).
3. Evaluate safety signals epidemiologically (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, and regulatory teams.
5. Draft confidential summaries for regulatory authorities.
6. Follow operational procedures diligently, respecting deadlines.
7. Analyze pharmacoepidemiological literature for safety signals/SER, RMP, PBRER/PSUR.
8. Review protocols, analysis plans, and study reports for PASS (Post-Authorization Safety Studies).
9. Ensure timely submission of PASS study documents to regulatory authorities.

Your profile:

• Master's degree (BAC+5), PhD, PharmD in public health, epidemiology, or related field.
• At least 5 years of experience in a similar role.
• Project management skills and ability to work across multidisciplinary teams.
• Good listening skills and diplomacy.
• Fluent in English (written and spoken); French skills are a plus.

Who are we?

• Leading global CRO with expertise and flexibility in clinical trials.
• Partnering with pharmaceutical, biotech, cosmetic, medical device companies worldwide.
• Operating in 10 countries across 3 continents with over 1000 professionals.
• Part of ALTEN Group since 2014, continuously expanding.

Why join us?

• Make a positive impact on global health through groundbreaking clinical research.
• Career development with coaching, mentoring, and growth opportunities.
• Commitment to diversity, equality, and inclusion, promoting respect and valuing differences.

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