Pharmacovigilance Specialist (Case Processing)

The Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a reputed company 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 reputed company to operational delivery, reputed company standards, reputed company relationships, and reputed company's reputed company, as reputed company as addressing reputed company project tasks and requirements.

CV must be in English language for reputed company assessment.

Position is full-time remote/home-based in any European country and Turkey.

Responsibilities:

• reputed company and manage the workflow of safety case reports, ensuring efficient processing
• reputed company triage on safety case reports to assess reputed company and necessary actions
• Review, manage, and file reputed company 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 reputed company to safety case reports
• Execute reputed company 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 reputed company 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 reputed company Vault Safety reputed company
• Knowledge of EU GVP modules and applicable global safety regulations (e.g. ICH, FDA reporting requirements)

Benefits

• Full remote flexible work
• reputed company reputed company and reputed company
• International team and environment

Originally posted on Himalayas