ContractedPharmacovigilance Services

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Contracted Pharmacovigilance Services

Pharmacovigilance

Through PharmaSoft, professional process management is provided according to the standards of a "Contracted Pharmacovigilance Service Organization" certified by authorized health authorities. All operational business processes are carried out through the officially audited and approved PharmaBASE database and PharmaSEARCH literature search systems, based on quality, reliability, and efficacy criteria. This ensures that all pharmacovigilance services provided are conducted in full compliance with national and international regulations.

Our Core Pharmacovigilance Competencies

Regulatory Compliance

All operational business processes are managed in full compliance with TİTCK and EMA legal standards

Scientific Accuracy

Performing detailed case analyses and precise exposure calculations based on high clinical accuracy

Quality Control

Establishing effective and proactive quality control mechanisms that minimize potential errors in processes

Process Continuity

Ensuring uninterrupted service understanding and full business continuity guarantee in operations, thanks to the strong technological infrastructure

PharmaSoft Pharmacovigilance Team
Pharmacovigilance Quality Steps

Pharmacovigilance Department Service

As a certified "Contracted Pharmacovigilance Service Organization," we ensure that all pharmacovigilance responsibilities are undertaken at the highest quality standards. Within the framework of current regulations and Good Pharmacovigilance Practices (GVP) (IFU), we ensure the complete management of operational processes and the timely fulfillment of legal obligations. With a commitment to quality and efficient service, we ensure business continuity, guaranteeing the uninterrupted and secure conduct of pharmaceutical safety operations in compliance with legal authorities.

Pharmacovigilance Outsourcing Service

The selection processes for expert personnel, fully aligned with organizational expectations, are conducted using advanced competency-based interview techniques. This method allows for a detailed assessment of candidates' technical and behavioral competencies, ensuring the identification of the profile best suited to operational needs.
Newly employed personnel receive comprehensive on-the-job orientation training from experienced instructors in accordance with current legal requirements and company procedures.
By combining professional recruitment and training processes, a cohesive workforce that operates with high efficiency is created, guaranteeing maximum operational success.

Pharmacovigilance Reports

The following systematic and specialized processes are applied in the preparation of high-quality pharmacovigilance reports, which result in full approval from administrative health authorities:
  • Comprehensive Literature Review: Conducting thorough literature reviews and medical resource research.
  • Global and Local Regulatory Compliance: Full compliance with current quality standards of administrative authorities, primarily TİTCK and EMA.
  • Use of Current Templates: Processing through the most current and official reporting formats published by the authorities.
  • Clinical Accuracy and Analysis: Performing precise case analyses and interpretation studies based on high clinical accuracy.
  • Exposure Calculations: Providing functional exposure calculations based entirely on scientific principles.
  • Cumulative Data Tables: Creating comprehensive data tables that strategically summarize large volumes of cumulative data.
  • Advanced Quality Control: Operating effective quality control mechanisms that proactively aim to minimize potential errors.