Apprenti Global Patient Safety
il y a 1 jour
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
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