Pharmacovigilance Specialist (Case Processing)

Biomapas

7d•Remote

About The Position

The Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a focus on safety case reporting, processing of safety case report data, and literature screening activities. The role involves communication with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding potential risks related to operational delivery, quality standards, client relationships, and the company's reputation, as well as addressing ad hoc project tasks and requirements.

Requirements

University degree in Life Science field
At least 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry
Proficiency in both verbal and written local language and English
Strong expertise with MS Office
Knowledge of EU GVP modules and applicable global safety regulations (e.g. ICH, FDA reporting requirements)

Nice To Haves

Beneficial experience with Veeva Vault Safety system

Responsibilities

Oversee and manage the workflow of safety case reports, ensuring efficient processing
Perform triage on safety case reports to assess priority and necessary actions
Review, manage, and file source documentation in compliance with regulatory requirements
Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluation
Conduct follow-up activities and manage queries related to safety case reports
Execute quality control checks on data entry and case processing to ensure accuracy and compliance
Reconcile safety case reports to ensure consistency and completeness of data
Prepare line listings to summarize and report on safety case data