Détails de l'annonce
Référence:
138981
Publiée le:
15 juillet 2021
Type de poste:
CDI
Lieu de travail:
Cite El Khadra, Tunis, Tunisie
Expérience:
Entre 1 et 2 ans
Étude:
Doctorat
Disponibilité:
Plein temps
Langues:
Anglais
Mobilité:
International
Entreprise:
anonymous logo
PRODUCTLIFE GROUP
Secteur: recrutement / ressources humaines
Taille: Entre 200 et 500 employés
Description de l'annonce:

We are looking for a Medical Writer to have responsibility for allocated tasks within Medical Writing Platform.


  • Contribute to Medical Writing activities within the Medical information and vigilances Business Unit.
  • Prepare, reviews and provide feedback for safety reports including: Signal detection, Risk Management Plans (RMPs) Addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs) and Development Safety Update Reports (DSURs).
  • Contribute to the production of client administrative documents to be included in regulatory submissions (i.e. Briefing packages to HAs, Ethics Committees documentation).
  • Assist in the preparation of Standard Operating procedures (SOPs) and Working Practice Documents.
  • To ensure adherence to GVP, ICH guidelines, SOPs, and client requirements.
Education
Bachelor's degree in pharmacy; physician or scientific;

Experience

  • Proved medical writing experience;
  • At least 2 years of Signal detection working experience
Skills
  • Process oriented with good attention to detail
  • Excellent organizational skills
  • Experience in signal detections, RMP, PSURs and DSURs
  • Fluent in English for daily contacts