You are a highly skilled professional with a passion for the world of life sciences and clinical research. You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people's lives. Come and join Aixial Group to contribute to shaping the future of clinical research!
We are currently looking for a Pharmacoepidemiologist (M/F) to carry out the following tasks (non-exhaustive list):
- Ensuring the scientific quality of entrusted studies (protocols, statistical analysis plans, study reports, result interpretation, study documents, project meetings)
- Ensuring the operational follow-up of entrusted studies (management of service providers, management of internal procedures related to studies)
- Managing the epidemiological evaluation of safety signals (review and analysis of scientific literature)
- 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)
- Writing summaries in a confidential context towards regulatory authorities
- Carefully following operational procedures while respecting deadlines
- Analyzing pharmacoepidemiological scientific literature for safety signals / SER, RMP, PBRER / PSUR
- Reviewing protocols, statistical analysis plans, and study reports for PASS (Post-Authorisation Safety Study)
- Ensuring compliance with submission timelines of PASS study documents to regulatory authorities
Your profile :
- You hold a Master's degree (BAC+5), PhD, PharmD with specialization in public health, epidemiology, or an equivalent field
- You have at least 5 years of experience in a similar position
- You are capable of managing projects and working transversally in multidisciplinary teams: medical, regulatory, marketing, etc.
- You possess good listening skills and diplomacy
- You are fluent in English (written and spoken)
- Proficiency in French would be a plus
Who Are We?
- We are one of the world’s leaders in CRO (Contract Research Organisation), with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.
- We work with global pharmaceutical, biotech, cosmetic, medical device, and other companies, providing innovative and scalable solutions.
- We operate in 10 countries across 3 continents, with over 1000 talented professionals dedicated to making a positive impact in the life sciences industry.
- We have been part of the ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activities worldwide.
Why Join Us?
- Make a positive impact by being at the forefront of projects that bring groundbreaking advancements in clinical research, positively impacting millions of lives globally.
- Career development: We are committed to empowering our team and fostering a positive, supportive environment that promotes growth, flexibility, and teamwork. At Aixial Group, you will receive coaching and mentorship to advance your professional and personal growth.
- Our commitment to diversity, equality, and inclusion: We aim to create a workforce that promotes dignity and respect, recognizes and values individual differences, and allows each employee to give their best. Gender equality is central to our development strategy.
Aixial Group continues to grow and is recruiting in the clinical trial professions.
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