PHARMASOFT CODE OF ETHICS AND BUSINESS PRINCIPLES DECLARATION

PharmaSoft, as a contracted pharmacovigilance service provider, offers pharmacovigilance department services, regulatory consultancy, and pharmacovigilance software solutions to companies operating in the pharmaceutical sector. In all our services, we prioritize ethical values, business principles, professional responsibility, and legal compliance. This code of ethics and business principles declaration outlines PharmaSoft’s business approach and its commitments to stakeholders.

 1. Integrity and Transparency

Integrity: We commit to being honest and straightforward in all our business relationships and activities.

Transparency: We aim to be clear and understandable in all our communications and reporting. We act as transparently as possible while adhering to confidentiality policies in information sharing.

 2. Professionalism

Expertise: We participate in continuous training and development activities to maintain the highest level of expertise in pharmacovigilance.

Quality: We strive to maintain and continuously improve the quality of the services we provide.

 3. Compliance with Laws and Regulations

PharmaSoft operates in full compliance with applicable national and international regulations in all areas of activity. We provide services in accordance with the regulations of the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Turkish Medicines and Medical Devices Agency (TMMDA). Additionally, we ensure full compliance with the Law on the Protection of Personal Data No. 6698 (KVKK) and other relevant data protection regulations when processing and storing personal data. All data is processed solely for lawful purposes and is securely protected.

 4. Information Security and Respect for Confidentiality

All personal, medical, and commercial data belonging to our clients and stakeholders are processed only within the limits of the law and based on explicit consent or contractual obligation. We work in full compliance with all relevant regulations, particularly the KVKK and the European Union General Data Protection Regulation (GDPR).

In this context:

• Data security is ensured through technical and administrative controls compliant with international standards such as ISO 27001.
• All employees and business partners receive regular training on data security and ethics.
• Continuous risk assessment is conducted to prevent data breaches; in the event of a breach, immediate intervention is carried out and relevant parties are informed.

 5. Professional Impartiality and Ethical Conduct

PharmaSoft conducts its activities without allowing any conflict of interest. The services we offer to our clients are based on scientific, ethical, and impartial principles.
Employees are required to notify the Human Resources department in advance of any situation that may conflict with their duties or benefit themselves or their first-degree relatives.

 6. Anti-Corruption and Anti-Bribery

At PharmaSoft, we maintain a zero-tolerance policy against bribery and corruption.

• No employee or representative may offer or accept gifts, payments, or services intended to secure an improper advantage.
• Any acts of bribery or corruption involving public officials, clients, or suppliers are strictly prohibited.
• Full compliance with these principles is ensured in all our activities.
• Suspicious situations must be reported immediately to hr@pharmasoft.com.tr. Whistleblowers are protected against retaliation.

 7. Scientific Accuracy and Quality

Scientific basis and quality are essential in all our services. Our expert team prioritizes staying current and embracing continuous development.

 8. Respect for Our Business Partners and Employees

We maintain respectful, inclusive, and professional relationships with all our stakeholders. We provide an equitable, development-oriented, and safe working environment for our employees.
Discrimination, sexual harassment, mobbing, and similar unethical behaviors are subject to zero tolerance. Such situations must be reported to hr@pharmasoft.com.tr and will be handled with care and diligence.

 9. Employee Responsibilities

Teamwork: We value teamwork and collaboration. We recognize and encourage each employee’s contribution.

Continuous Development: We support our employees’ ongoing development. We offer training and career development opportunities.

 10. Digital Ethics and Social Media Use

Employees must adopt a respectful tone and behavior that does not damage PharmaSoft’s corporate image while representing the company on digital platforms. Unauthorized sharing of internal information is strictly prohibited.

 11. Sustainability and Social Responsibility

While serving the pharmaceutical sector, we consider not only legal compliance but also our responsibility to society and the environment. We support an ethical, sustainable, and socially beneficial corporate culture.

 12. Evaluation and Resolution of Ethical Violations

PharmaSoft expects all employees and business partners to comply with this code of ethics. A zero-tolerance policy is applied to all unethical behavior. Depending on the nature of the violation, sanctions such as warnings, disciplinary action, job reassignment, or termination of employment may be implemented. All processes are carried out transparently, fairly, and with respect for confidentiality.