Requirements: English
Company: AIXIAL GROUP
Region: Nantes , Pays de la Loire
You are a highly skilled professional with 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 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 authoritiesCarefully following operational procedures
while respecting deadlinesAnalyzing pharmacoepidemiological scientific literature
for safety signals/SER, RMP, PBRER/PSURReviewing 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 have a Master''s degree ( BAC+5 ), PhD, PharmD with a specialization in public
health, epidemiology,
or equivalent field of studyYou have at least
5 years of experience in a similar positionAbility to
manage a project
and
work transversally
in multidisciplinary teams: medical, regulatory, marketing, etcYou have good
listening skills and diplomacyYou are
fluent in English
(written and spoken)You have a
professional or fluent level in French
would be a plus
Who Are we?
We are
one of the worlds 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 many other companies around the globe, providing them with innovative and scalable solutions.We are
operating in 10 countries across 3 continents , bringing together
over 1000 talented
professionals
dedicated to make a positive impact in the life sciences industry.We have been
part of ALTEN Group since 2014
and are continuously exploring new opportunities to expand our activity worldwide.
Why Join Us ?
Make a positive impact and be at the forefront of project : You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of peoples lives globally.
Career Development : People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.
Our commitment to Diversity, Equality, and Inclusion : We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. Gender equality is at the core of the development strategy of Aixial Group.
Aixial Group
continues to
grow, and to recruit
in the clinical trial professions.
Join us, and discover our website to follow the news of our offers :
https://www.aixialgroup.com/join-us/