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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 contribute to shaping the future of clinical research!
We are seeking a Pharmacoepidemiologist (M/F) to perform the following key responsibilities:
- Ensure the scientific quality of entrusted studies, including protocols, statistical analysis plans, study reports, and project meetings.
- Manage operational follow-up of studies, including overseeing service providers and internal procedures.
- Conduct epidemiological evaluations of safety signals through literature review and analysis.
- Contribute to updates of crisis management plans, respond to health authority queries, and participate in cross-functional meetings with pharmacovigilance, medical affairs, and regulatory affairs.
- Draft summaries for regulatory authorities in a confidential context.
- Follow operational procedures carefully, respecting deadlines.
- Analyze pharmacoepidemiological scientific literature for safety signals, SER, RMP, PBRER/PSUR.
- Review protocols, statistical analysis plans, and study reports for PASS (Post-Authorisation Safety Study).
- Ensure timely submission of PASS study documents to regulatory authorities.
Your profile:
- Master's degree (BAC+5), PhD, PharmD in public health, epidemiology, or equivalent.
- At least 5 years of experience in a similar role.
- Ability to manage projects and work across multidisciplinary teams.
- Good listening skills and diplomacy.
- Fluent in English (written and spoken).
- Professional or fluent in French is a plus.
About Us:
- We are a global leader in CRO, committed to delivering efficient clinical trials.
- We collaborate with pharmaceutical, biotech, cosmetic, medical device companies worldwide, offering innovative solutions.
- Operating in 10 countries across 3 continents, with over 1000 professionals dedicated to making a positive impact in life sciences.
- Part of the ALTEN Group since 2014, continuously expanding our global presence.
Why Join Us?
- Make a positive impact by participating in groundbreaking clinical research affecting millions worldwide.
- Enjoy career development opportunities, mentorship, and a supportive environment fostering growth and teamwork.
- We are committed to Diversity, Equality, and Inclusion, promoting dignity, respect, and gender equality.
Aixial Group continues to grow and recruit in clinical trial professions. Join us and follow our news and offers on our website.