Delta PV, a leading pharmacovigilance service provider headquartered in Istanbul, Türkiye, has been part of the Biomapas group since 1 August 2025. As such, this vacancy is advertised on behalf of Delta PV within the Biomapas organization.
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 and the processing of safety case report data. The Specialist may assume the role of Primary or Secondary Project Responsible for the assigned project. 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. The Pharmacovigilance Specialist may also contribute to the review and update of internal company procedures.
Key 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
- A minimum of a Bachelor’s Degree in a life sciences 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.
- Excellent written and oral communication skills in both English and the local language.
- Strong expertise in MS Office applications.
Benefits
- Professional growth and career opportunities
- International team and environment
- Monthly bonuses
- Remote work