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.
CV must be in English language for further assessment.
Position is full-time remote/home-based in any European country and Turkey.
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
Experience of clinical trial case processing in a safety database.
Proficiency in both verbal and written local language and English
Strong expertise with MS Office
Beneficial experience with Veeva Vault Safety system
Knowledge of EU GVP modules and applicable global safety regulations (e.g. ICH, FDA reporting requirements)
Benefits
Full remote flexible work
Professional growth and career opportunities
International team and environment
Biomapas is a regulatory affairs and pharmacovigilance services company that supports pharmaceutical, medical device, food supplement, and cosmetics clients. The company provides comprehensive regulatory compliance services including regulatory affairs support, pharmacovigilance operations, adverse event management, and regulatory intelligence. Biomapas works with an international team to manage client interactions with national authorities, maintain regulatory databases, and ensure data integrity and safety compliance across multiple product portfolios.
