Contracted Pharmacovigilance
Service Organization
Within the scope of the certificate audit conducted by the Agency;
✅ All our business processes,
✅ PharmaBASE pharmacovigilance database,
✅ PharmaSEARCH is our literature search application,
Audited and officially approved in terms of quality, reliability and effectiveness.
Accordingly, our services are certified to comply with national and international quality standards.
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RMP & ACO (AddCo)
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PSUR & PBRER
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PSMF
Pharmacovigilance
Reports
PharmaSoft implements the following systematic and specialized processes in all of its pharmacovigilance reports to deliver high-quality outputs that conclude with regulatory authority approval:
✅ Literature screening and scientific source research,
✅ Full compliance with current standards set by regulatory authorities such as the TİTCK and EMA,
✅ Utilization of the most up-to-date reporting templates as mandated by authorities,
✅ Case analyses based on clinical accuracy,
✅ Scientifically grounded and functional exposure assessments,
✅ Comprehensive tables summarizing cumulative data,
✅ Robust quality control mechanisms aimed at minimizing errors.
Through these structured processes, PharmaSoft adopts the principle of scientific accuracy, regulatory compliance, and trustworthiness in the eyes of regulatory authorities in pharmacovigilance reporting.
✅ Literature screening and scientific source research,
✅ Full compliance with current standards set by regulatory authorities such as the TİTCK and EMA,
✅ Utilization of the most up-to-date reporting templates as mandated by authorities,
✅ Case analyses based on clinical accuracy,
✅ Scientifically grounded and functional exposure assessments,
✅ Comprehensive tables summarizing cumulative data,
✅ Robust quality control mechanisms aimed at minimizing errors.
Through these structured processes, PharmaSoft adopts the principle of scientific accuracy, regulatory compliance, and trustworthiness in the eyes of regulatory authorities in pharmacovigilance reporting.
Pharmacovigilance
Department Service
As a Contract Pharmacovigilance Service Provider, we undertake all pharmacovigilance responsibilities in accordance with the highest standards.
Within the framework of current regulations and Good Pharmacovigilance Practices , we comprehensively manage your pharmacovigilance processes and ensure the fulfillment of all legal obligations.
With our commitment to providing high-quality and efficient services, we safeguard business continuity and enable you to meet your pharmacovigilance obligations in a seamless and secure manner.
Within the framework of current regulations and Good Pharmacovigilance Practices , we comprehensively manage your pharmacovigilance processes and ensure the fulfillment of all legal obligations.
With our commitment to providing high-quality and efficient services, we safeguard business continuity and enable you to meet your pharmacovigilance obligations in a seamless and secure manner.
Pharmacovigilance
Outsourcing Service
At PharmaSoft, personnel selection is conducted using competency-based interview techniques to ensure full alignment with client expectations. This method enables the assessment of both technical and behavioral competencies, thereby identifying the most suitable candidate in accordance with client requirements.
Hired personnel undergo a comprehensive on-the-job orientation training delivered by experienced instructors, in accordance with regulatory requirements and client-specific procedures. This training facilitates rapid adaptation to operational workflows and ensures high levels of efficiency in job performance.
As a result, through professional recruitment and training processes, a cohesive and productive workforce is established, thereby ensuring client satisfaction and operational success.
Hired personnel undergo a comprehensive on-the-job orientation training delivered by experienced instructors, in accordance with regulatory requirements and client-specific procedures. This training facilitates rapid adaptation to operational workflows and ensures high levels of efficiency in job performance.
As a result, through professional recruitment and training processes, a cohesive and productive workforce is established, thereby ensuring client satisfaction and operational success.
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Our Products
Our Services
Demo Request
If you need any information or request a demo about our services and products, please contact us by following this link.
Contact Us
Fetih Mah. Tahralı Sk. Kavakyeli İş Merkezi No:7 A Blok Kat:10 D: 25
Ataşehir/İstanbul/Turkey
☎ +90 216 326 77 12
📠 +90 216 428 39 71
📧 contact＠pharmasoft.com.tr
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