Pharmacovigilance Specialist (Case Processing) at Biomapas

, , Bulgaria -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

17 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Safety Case Reporting, Data Processing, Literature Screening, Quality Control, Medical Review, Causality Assessment, Expectedness Assessment, SDB Data Entry, Narrative Writing, Follow-Up Activities, Regulatory Compliance, MS Office, Communication, Team Collaboration, Workflow Management

Industry

Research Services

Description

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. Position is in any EU country. 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. A minimum of a Bachelor’s Degree in a life sciences/medical field. At least 1 year of experience in safety and pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry, or newly graduated with relevant educational background. Proficiency in both verbal and written locala language and English. Strong expertise in MS Office applications. Professional growth and career opportunities International team and environment Bonus based on monthly case numbers

Responsibilities

The Pharmacovigilance Specialist will oversee and manage the workflow of safety case reports, ensuring efficient processing and compliance with regulatory requirements. The role includes performing triage on safety case reports, conducting quality control checks, and preparing line listings to summarize safety case data.