PRODUCTLIFE GROUP recrutement - Data Officer - Tunis

Date de publication	Type de poste	Lieu de travail	Expérience	Étude	Disponibilité	Langues
9 juin 2021	CDI	Cite El Khadra, Tunis, Tunisie	Entre 1 et 2 ans	Formations professionnelles	Plein temps	Français , Anglais

We are looking for a Case Officer to have responsibility for allocated tasks within the pharmacovigilance activities delivered by the platform.

Participate in pre-marketing and post marketing activities and interaction with health authorities on behalf of PLG’s customers
To contribute to the production of client administration documents to be included in regulatory submissions
Undertake data entry and document management for PV aspects of allocated studies
Systems management and administration
Understand and interpret clinical and scientific reports to allow the accurate capture of safety data
Responsible for triage, case processing and document management of safety documentation. Safety information to manage can include, Averse Events (AEs), Serious Adverse Events (SAEs), reports from clinical trials, spontaneous reports, health authority reports, literature reports, medical device reports and cosmetovigilance case reports.
To manage safety mailbox and ensure that case timelines are accurately assessed and recorded for continued compliance
Liaise with healthcare professionals (HCP) and study investigators to collect follow up information
Assist members of the case management team with project related tasks as applicable
Activities relating to Eudravigilance and MHRA ICSR Submissions portal, such as ICSR download, MLM
To assist in preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
To participate in training required for PLG staff
To comply with all policies and procedures to meet quality and business requirements

Education

Bachelor’s degree in science related field

Experience

1 year of previous experience is desirable

Skills

PRODUCTLIFE GROUP recrutement – Data Officer – Tunis