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Medical Writer

PRODUCTLIFE GROUP Cite El Khadra, Tunis Publiée le 15 juillet 2021

Expirée

Détails de l'annonce

Référence

138981

Date de publication

15 juillet 2021

Type de contrat

CDI

Lieu de travail

Cite El Khadra, Tunis, Tunisie

Expérience requise

Entre 1 et 2 ans

Niveau d'études

Doctorat

Disponibilité

Plein temps

Langues

Anglais

Mobilité

Internationale

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Taille: Entre 200 et 500 employés

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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