Our training goes beyond theory — it helps your team understand not just how to report adverse reactions, but why it matters.

🎯 Our goal:
To improve the quality, accuracy, and timeliness of adverse event reporting-while building company-wide awareness around pharmacovigilance responsibilities.

✅ Content tailored for all employee levels
✅ Practical examples based on real-life cases
✅ Customized sessions using examples relevant to your organization

We help embed a culture of pharmacovigilance into your company — from the inside out.

🎓 Our training content is developed in full alignment with current regulations and standards, incorporating feedback and guidance from TMMDA (Turkish Medicines and Medical Devices Agency).

🎥 Presentations are enriched with videos, visuals, and real case examples — to ensure participants don’t just hear the information, but truly understand and retain it.

💬 We deliver clear, engaging, and practical content — far from dry technical slides — to build a solid foundation in pharmacovigilance.

Say goodbye to boring trainings — and hello to inspection-ready, memorable learning experiences.

Not every team member starts from the same point — and our trainings are designed accordingly.

PharmaSoft’s pharmacovigilance training is offered in three distinct levels, tailored to the roles and responsibilities of your staff:

🔵 Beginner Level
For newcomers and support staff: key definitions, basic PV concepts, and an introduction to the reporting process.

🟠 Intermediate Level
For team members directly involved in PV tasks: practical workflows, case examples, and regulatory context.

⚫ Advanced Level
For specialists and decision-makers: in-depth analysis of legislation, inspection readiness, and managing critical PV activities.

The right knowledge, at the right level — that’s how learning makes an impact.

To ensure clarity and maximum engagement, our trainings are available in multiple language options:

🇹🇷 Turkish
🇬🇧 English
🇷🇺 Russian

Because effective training starts with speaking the right language.

At the end of the training, participants take a brief assessment to evaluate their understanding of the content.

✅ A minimum score of 80% is required for successful completion.

✅ Participants who do not meet this threshold are offered a free repeat session.

This assessment is designed not only to measure knowledge, but also to identify areas that may need reinforcement — helping ensure learning is complete and effective.

Because a strong pharmacovigilance system starts with strong knowledge.

A Certificate of Participation is issued by
PharmaSoft Ilac Bilisim Danismanlik Hiz. Ltd. Sti.
to participants who successfully complete the training.

The certificate confirms the participant’s completion of the program and their active engagement with the training content.

Throughout the program, participants will engage with key processes, including:

🔍 Detection of potential signals
✅ Validation and confirmation
📊 Analysis and prioritization
📌 Development and evaluation of action proposals

The objective is not merely to recognize potential signals, but to manage them effectively—providing timely and accurate data to support regulatory decision-making.

📘 The training is developed in accordance with current regulations and Good Pharmacovigilance Practices (GVP) Guideline – Module VII: Signal Management.

🧠 Participants gain comprehensive knowledge on all key steps in signal management, including identification, validation, prioritization, assessment, and formulation of action recommendations for potential signals.

🔬 The content also covers traditional and quantitative signal detection methods, quality standards, and organizational responsibilities.

🎥 Sessions are enriched with visuals, videos, and real case scenarios.

Participants don’t just listen — they actively experience signal management through visual and hands-on learning.

Not every team member starts from the same point — and our trainings are designed accordingly.

PharmaSoft’s pharmacovigilance training is offered in three distinct levels, tailored to the roles and responsibilities of your staff:

🔵 Beginner Level
For newcomers and support staff: key definitions, basic PV concepts, and an introduction to the reporting process.

🟠 Intermediate Level
For team members directly involved in PV tasks: practical workflows, case examples, and regulatory context.

⚫ Advanced Level
For specialists and decision-makers: in-depth analysis of legislation, inspection readiness, and managing critical PV activities.

The right knowledge, at the right level — that’s how learning makes an impact.

To ensure clarity and maximum engagement, our trainings are available in multiple language options:

🇹🇷 Turkish
🇬🇧 English

Because effective training starts with speaking the right language.

At the end of the training, participants take a brief assessment to evaluate their understanding of the content.

✅ A minimum score of 80% is required for successful completion.

✅ Participants who do not meet this threshold are offered a free repeat session.

This assessment is designed not only to measure knowledge, but also to identify areas that may need reinforcement — helping ensure learning is complete and effective.

Because a strong pharmacovigilance system starts with strong knowledge.

A Certificate of Participation is issued by
PharmaSoft Ilac Bilisim Danismanlik Hiz. Ltd. Sti.
to participants who successfully complete the training.

The certificate confirms the participant’s completion of the program and their active engagement with the training content.

Participants will gain hands-on knowledge in:

🔎 Identifying and characterizing risks
🛡️ Developing prevention and risk minimization strategies
📄 Preparing a Risk Management Plan (RMP) in line with the latest regulatory guidance

The goal is not just to complete an RMP — but to understand the process and integrate effective risk management strategies.

✅ The training is designed in line with current regulations and Good Pharmacovigilance Practices (GVP) Module VI – Risk Management Systems.

✅ Participants will gain a comprehensive understanding of RMP structure, modular safety specifications, planning of risk minimization measures, and evaluation of their effectiveness.

✅ The content is enriched with real-life examples, visuals, and video materials to bridge theory and practice effectively.

💡 Because a Risk Management Plan should not only be written — it must also work.

Not every team member starts from the same point — and our trainings are designed accordingly.

PharmaSoft’s pharmacovigilance training is offered in three distinct levels, tailored to the roles and responsibilities of your staff:

🔵 Beginner Level
For newcomers and support staff: key definitions, basic PV concepts, and an introduction to the reporting process.

🟠 Intermediate Level
For team members directly involved in PV tasks: practical workflows, case examples, and regulatory context.

⚫ Advanced Level
For specialists and decision-makers: in-depth analysis of legislation, inspection readiness, and managing critical PV activities.

The right knowledge, at the right level — that’s how learning makes an impact.

To ensure clarity and maximum engagement, our trainings are available in multiple language options:

🇹🇷 Turkish
🇬🇧 English

Because effective training starts with speaking the right language.

At the end of the training, participants take a brief assessment to evaluate their understanding of the content.

✅ A minimum score of 80% is required for successful completion.

✅ Participants who do not meet this threshold are offered a free repeat session.

This assessment is designed not only to measure knowledge, but also to identify areas that may need reinforcement — helping ensure learning is complete and effective.

Because a strong pharmacovigilance system starts with strong knowledge.

A Certificate of Participation is issued by
PharmaSoft Ilac Bilisim Danismanlik Hiz. Ltd. Sti.
to participants who successfully complete the training.

The certificate confirms the participant’s completion of the program and their active engagement with the training content.

It’s the first document an inspector asks for — and the one that tells your system’s whole story.

This training provides both regulatory insight and practical guidance on how to properly prepare, update, and archive the Pharmacovigilance System Master File (PSMF).

🔍 Structure and mandatory components
📅 Update and version control procedures
🗂 Archiving methods for inspection readiness

The PSMF isn’t just a document — it’s the memory of your pharmacovigilance system.

✅ This training is developed in line with current regulations and Good Pharmacovigilance Practices (GVP) Module V – Pharmacovigilance System Master File (PSMF) guidance.

✅ It covers in detail the preparation, maintenance, and inspection-readiness of the Pharmacovigilance System Master File (PSMF).

✅ The content is enriched with videos, visuals, and real-world examples to support practical learning.

✅ Participants will explore each section of the PSMF — including pharmacovigilance processes, quality systems, organizational structure, computerized systems, and change control — and learn how to evaluate and manage them effectively.

✅ Annex I topics, such as change history tracking, version control, and the use of tracking registers, are also covered with a practical approach, as they are frequently reviewed during inspections.

A well-maintained PSMF is more than a regulatory requirement — it’s the backbone of a strong and transparent pharmacovigilance system.

Not every team member starts from the same point — and our trainings are designed accordingly.

PharmaSoft’s pharmacovigilance training is offered in three distinct levels, tailored to the roles and responsibilities of your staff:

🔵 Beginner Level
For newcomers and support staff: key definitions, basic PV concepts, and an introduction to the reporting process.

🟠 Intermediate Level
For team members directly involved in PV tasks: practical workflows, case examples, and regulatory context.

⚫ Advanced Level
For specialists and decision-makers: in-depth analysis of legislation, inspection readiness, and managing critical PV activities.

The right knowledge, at the right level — that’s how learning makes an impact.

To ensure clarity and maximum engagement, our trainings are available in multiple language options:

🇹🇷 Turkish
🇬🇧 English

Because effective training starts with speaking the right language.

At the end of the training, participants take a brief assessment to evaluate their understanding of the content.

✅ A minimum score of 80% is required for successful completion.

✅ Participants who do not meet this threshold are offered a free repeat session.

This assessment is designed not only to measure knowledge, but also to identify areas that may need reinforcement — helping ensure learning is complete and effective.

Because a strong pharmacovigilance system starts with strong knowledge.

A Certificate of Participation is issued by
PharmaSoft Ilac Bilisim Danismanlik Hiz. Ltd. Sti.
to participants who successfully complete the training.

The certificate confirms the participant’s completion of the program and their active engagement with the training content.

This training aims to enhance participant competency in preparing, archiving, and submitting Periodic Benefit-Risk Evaluation Reports (PBRER) in accordance with current guidelines and best practices.

📄 Structuring content in line with regulatory expectations
📊 Scientifically analyzing the benefit-risk balance
🗂 Preparation / archiving standards and timely submission obligations

All topics are delivered through a blend of theory, real-world examples, and practical exercises.

PBRERs are more than just regulatory reports — they are strategic reflections of a product’s safety throughout its lifecycle.

✅ This training is based on the Good Pharmacovigilance Practices (GVP) – Module III, and is structured around the content, format, and regulatory expectations of the PBRER.

✅ Participants will learn how to:

📌 Scientifically evaluate the benefit-risk balance of a product post-authorization
📌 Structure and populate key report sections (introduction, executive summary, safety data, evaluations, conclusions)
📌 Submit and archive reports in compliance with national and international deadlines

✅ The course includes sample reports, visual content, and video walkthroughs to support real-world application.

PBRER preparation is more than just a document — it’s a tool for ongoing safety stewardship throughout a product’s lifecycle.

Not every team member starts from the same point — and our trainings are designed accordingly.

PharmaSoft’s pharmacovigilance training is offered in three distinct levels, tailored to the roles and responsibilities of your staff:

🔵 Beginner Level
For newcomers and support staff: key definitions, basic PV concepts, and an introduction to the reporting process.

🟠 Intermediate Level
For team members directly involved in PV tasks: practical workflows, case examples, and regulatory context.

⚫ Advanced Level
For specialists and decision-makers: in-depth analysis of legislation, inspection readiness, and managing critical PV activities.

The right knowledge, at the right level — that’s how learning makes an impact.

To ensure clarity and maximum engagement, our trainings are available in multiple language options:

🇹🇷 Turkish
🇬🇧 English

Because effective training starts with speaking the right language.

At the end of the training, participants take a brief assessment to evaluate their understanding of the content.

✅ A minimum score of 80% is required for successful completion.

✅ Participants who do not meet this threshold are offered a free repeat session.

This assessment is designed not only to measure knowledge, but also to identify areas that may need reinforcement — helping ensure learning is complete and effective.

Because a strong pharmacovigilance system starts with strong knowledge.

A Certificate of Participation is issued by
PharmaSoft Ilac Bilisim Danismanlik Hiz. Ltd. Sti.
to participants who successfully complete the training.

The certificate confirms the participant’s completion of the program and their active engagement with the training content.