Pharmacovigilance Specialist (Case Processing)

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.

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

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

Benefits

Professional growth and career opportunities

International team and environment

Bonus based on monthly case numbers

Apply To this Job

Company : Biomapas

Salary : Work from home .