Data Officer Tunisia

ProductLife Group (PLG) is a global consulting and outsourcing company supporting life sciences organizations throughout the product lifecycle.

Responsibilities:

Perform the initial triage and assessment of pharmacovigilance cases.
Process cases received from spontaneous reports, health authorities, scientific literature and other sources.
Perform pre-data entry and data entry of safety information into the pharmacovigilance database.
Review available case information and identify missing or incomplete data.
Prepare and send follow-up requests when additional information is required.
Update internal Excel trackers and case management tools.
Complete internal checklists and quality control activities.
Support CAPA-related checks and follow-up actions.
Archive case-related documents in accordance with internal procedures.
Ensure that cases are processed according to applicable timelines, SOPs and work instructions.
Collaborate with Pharmacovigilance Officers, medical writers, database administrators and other team members.
Support additional routine pharmacovigilance activities when required.

University degree in pharmacy, life sciences, biology, healthcare or another relevant scientific field.
A pharmacy degree would be considered an advantage but is not mandatory.

At least 6 months to 1 year of experience in pharmacovigilance case management.
Previous experience in safety data entry, case processing or drug safety activities.
Understanding of basic pharmacovigilance processes and regulatory reporting timelines.

French may be required for reviewing source documents and preparing case narratives or safety information in English.

Experience using a pharmacovigilance or safety database.
Knowledge of Safety Easy, Ennov or a similar pharmacovigilance system would be an advantage.
Good knowledge of Microsoft Excel.
Ability to work with trackers, checklists and regulated documentation.
Knowledge of pharmacovigilance terminology and case-processing procedures.