PERSONAL DATA PROTECTION NOTICE WITHIN THE SCOPE OF PHARMACOVIGILANCE ACTIVITIES

PharmaSoft İlaç Bilişim Danışmanlık Ltd. Şti. places great importance on personal data privacy and the confidentiality of private life within the scope of the company’s privacy policy. In accordance with the Law on the Protection of Personal Data No. 6698 (“KVKK”), as the Data Processor, we hereby inform you that any personal information about you obtained or to be obtained by our company, or shared with us by you (“personal data”), will be processed by our company within the framework described below and in accordance with the methods foreseen by the aforementioned Law. The collection, recording, storage, preservation, alteration, disclosure, transfer, and making accessible of your information by automatic or non-automatic means constitute “processing of personal data.”

Detailed information regarding the processing of your personal data under this Notice can be accessed at https://pharmasoft.com.tr/tr/pharmasoft/.

1. Purpose of Processing Personal Data

Pharmaceutical companies are required to conduct activities related to the detection, evaluation, identification, and prevention of adverse drug reactions (side effects) and other possible problems related to drugs during their use. These activities, known as pharmacovigilance, enable the monitoring of drug safety and, when necessary, the implementation of certain measures at national or international levels to protect public health.
All personal data received by our company regarding adverse drug reactions and other pharmacovigilance activities are used solely for pharmacovigilance purposes. Your personal data is collected and processed in compliance with KVKK and relevant regulations.
During pharmacovigilance activities, we collect the reporter’s name, contact information, and profession/affiliated institution. If necessary, additional personal data related to the medical history and health of the person experiencing the adverse event may also be collected.

2. Parties to Whom Personal Data May Be Transferred and Purpose of Transfer

The information you provide will be used to fulfill legal obligations stipulated by legislation related to drug safety monitoring and may be shared with the Turkish Medicines and Medical Devices Agency. Your data may also be entered anonymously into the World Health Organization’s database under the Drug Monitoring and Cooperation Program.

Our company may share the information you provide, when necessary, with our main group company, subsidiaries, business partners, and service providers (suppliers, legally authorized public institutions and organizations, and legally authorized private legal entities) for processing in the global pharmacovigilance database and for compliance with pharmacovigilance regulations.
Our company is also required to report some pharmacovigilance data to other health authorities in Europe and worldwide, including countries with different data protection levels. However, these reports contain detailed information about the event but only a limited amount of personal data:

• Patients: Information including age or date/year of birth, gender, and initials of the patient’s name (the patient’s full name is not disclosed).
• Reporter: Information such as name, profession, initials of first and last name, address, e-mail, and phone number provided to enable the institution to follow up with the reporter.

3. Method and Legal Basis of Personal Data Collection

Your personal data is collected either in paper form or electronically. Data related to pharmacovigilance is processed pursuant to Article 6, Paragraph 3 of Law No. 6698 for the purpose of protecting public health and preventive medicine, and your personal data is processed within the scope of Article 5, Paragraph 2(c) of the Law, which stipulates processing is mandatory for the data controller to fulfill its legal obligations.

4. Retention

Due to the importance of pharmacovigilance information (adverse event reports) for public health, reports must be retained for at least 10 years after the withdrawal of the drug from the market in the last country where it was marketed.

5. Rights of Data Subjects

As a data subject, you have the following rights pursuant to Article 11 of Law No. 6698:

• To learn whether your personal data is being processed,
• To request information if your personal data has been processed,
• To learn the purpose of processing your personal data and whether it is being used accordingly,
• To know the third parties domestic or abroad to whom your personal data has been transferred,
• To request correction of your personal data if it has been processed incompletely or incorrectly and to request notification of this correction to third parties to whom the data has been transferred,
• To request deletion or destruction of your personal data and notification of this to third parties if the reasons requiring processing have ceased despite lawful processing,
• To object to the emergence of a result against yourself by exclusively analyzing the processed data through automatic systems,
• To request compensation for damages in case of unlawful processing of your personal data.

However, due to pharmacovigilance legislation obligations, our company may not be able to delete or restrict the processing of data that has been processed for pharmacovigilance purposes.

You can submit your requests regarding your rights listed above via the methods specified in the PharmaSoft Personal Data Protection Law Disclosure and Consent Text available at https://pharmasoft.com.tr/tr/pharmasoft/. Upon receipt, your requests will be evaluated and finalized by our Company as soon as possible and in any case within 30 (thirty) days.

Data Processor Contact Information:

PharmaSoft İlaç Bilişim Danışmanlık Ltd. Şti.

Address: PharmaSoft Ilac Bilisim Dan. Hiz. Ltd. Sti.

Fetih Mh. Tahrali Sk. Kavakyeli Is Merkezi, A Blok No: 7 Kat: 10 D: 26 34704 Atasehir / ISTANBUL
E-mail: info@pharmasoft.com.tr