Pharmacovigilance Specialist – Case Processing (Remote)

About the role

The Pharmacovigilance Specialist will ensure the operational delivery of safety case reporting and literature screening activities at the project level. Working remotely, you will collaborate closely with the Pharmacovigilance Team Leader and Manager to manage risks, maintain quality standards, and support client relationships.

Key responsibilities

• Oversee and manage the workflow of safety case reports, ensuring efficient processing.
• Perform triage on case reports to assess priority and required actions.
• Review, manage, and file source documentation in line with regulatory requirements.
• Process safety case reports, including data entry, narrative writing, seriousness assessment, medical review, and reporting evaluation.
• Conduct follow‑up activities and manage queries related to safety case reports.
• Execute quality control checks on data entry and case processing.
• Reconcile reports to ensure data consistency and completeness.
• Prepare line listings to summarize safety case data.

Required profile

• University degree in a Life Sciences field.
• At least 1 year of experience in safety and pharmacovigilance within a pharmaceutical company or CRO.
• Experience with clinical trial case processing in a safety database.
• Proficiency in both written and spoken English and the local language.

Required skills

• Strong expertise with MS Office.
• Experience using Veeva Vault Safety system.
• Knowledge of EU GVP modules and global safety regulations (ICH, FDA reporting requirements).
• Ability to work with safety databases and perform case reconciliation.

What we offer

• Full remote flexible work.
• Professional growth and career opportunities.
• International team and collaborative environment.