ProductLife Group

Position Overview
We are looking for a Pharmacovigilance Data Officer to support our Patient Safety team in managing an increasing volume of pharmacovigilance cases.
The successful candidate will contribute to the triage, assessment, follow-up and data entry of safety cases received from different sources. The role requires strong attention to detail, good organizational skills and the ability to work in a regulated environment.
Main Responsibilities
<ul>
<li>Perform the initial triage and assessment of pharmacovigilance cases.</li>
<li>Process cases received from spontaneous reports, health authorities, scientific literature and other sources.</li>
<li>Perform pre-data entry and data entry of safety information into the pharmacovigilance database.</li>
<li>Review available case information and identify missing or incomplete data.</li>
<li>Prepare and send follow-up requests when additional information is required.</li>
<li>Update internal Excel trackers and case management tools.</li>
<li>Complete internal checklists and quality control activities.</li>
<li>Support CAPA-related checks and follow-up actions.</li>
<li>Archive case-related documents in accordance with internal procedures.</li>
<li>Ensure that cases are processed according to applicable timelines, SOPs and work instructions.</li>
<li>Collaborate with Pharmacovigilance Officers, medical writers, database administrators and other team members.</li>
<li>Support additional routine pharmacovigilance activities when required.</li>
</ul>
Education
<ul>
<li>University degree in pharmacy, life sciences, biology, healthcare or another relevant scientific field.</li>
<li>A pharmacy degree would be considered an advantage but is not mandatory.</li>
</ul>
Required Experience
<ul>
<li>At least 6 months to 1 year of experience in pharmacovigilance case management.</li>
<li>Previous experience in safety data entry, case processing or drug safety activities.</li>
<li>Understanding of basic pharmacovigilance processes and regulatory reporting timelines.</li>
</ul>
Language Requirements
<ul>
<li>Good professional level of English is required.</li>
<li>French language skills would be an advantage but are not mandatory.</li>
</ul>
French may be required for reviewing source documents and preparing case narratives or safety information in English.
Technical Skills
<ul>
<li>Experience using a pharmacovigilance or safety database.</li>
<li>Knowledge of Safety Easy, Ennov or a similar pharmacovigilance system would be an advantage.</li>
<li>Good knowledge of Microsoft Excel.</li>
<li>Ability to work with trackers, checklists and regulated documentation.</li>
<li>Knowledge of pharmacovigilance terminology and case-processing procedures.</li>
</ul>

Data Officer

Data Officer

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