Apprenti Global Patient Safety H/F

Title:

Apprenti Global Patient Safety H/F

Company:

Ipsen Innovation (SAS)

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

• Objectifs de la fonction

To gain first pharmacovigilance experience (clinical trial and post marketing legislation, ICSR processing/reporting, medical literature monitoring, signal management, periodic reporting, risk management activities. Gain MedDRA experience. Gain safety database experience).
To gain first experience in clinical trial pharmacovigilance (SAE/SUSAR management, periodic reporting, study documents review)
Acquisition of general notions on pharmacovigilance processes for products in development and post-marketing

Developing of soft and communication skills (Interaction with physicians and scientists responsible for other products within the GPS TA teams).

• Principales responsabilités et tâches

Ensure compliance with clinical trial legislation and company’s policies and SOPs during IPN60130 development program
Review SAE/SUSARs
Review of line listings
Review of literature results
Provide input in review of study documents
Quality Control of eTMF for ongoing studies

Contribute to other project & activities performed at GPS Rare Disease Team level to gain experience in managing pre-marketing and post marketing product development.

Participate to regular team meetings in the TA and across TAs ie “Safety Therapeutic Area Forum”.

• Etudes / Certifications / Expérience :

Science background, Master in Vigilance or Toxicology.
Business English speaking & writing

• Compétences techniques clés requises

Office Pack

#LI-Hybrid
#IpsenTraineeSquad
 

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.