Bayer takes product safety and your privacy seriously
Bayer Middle East FZE, Dubai, U.A.E (hereinafter “Bayer”, “us”, “our” and “we”) develops and markets prescription and over the counter medicines as well as medical devices and cosmetics, for human and veterinary use (“Bayer Health Products”). As a pharmaceutical company, Bayer has a legal responsibility to monitor the safety of all Bayer Health Products worldwide that we have in development or are marketing in any country.
Humans and animals vary in their biological reactions to medicinal products or medical devices and not all adverse reactions or events (side effects) associated with the use of medicinal products and medical devices can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing adverse events, however rare they may be in absolute terms, in the development and marketing phase from worldwide sources is of paramount importance.
Such monitoring of adverse events is called Pharmacovigilance (“PV”). PV requirements exist to allow us and competent regulatory authorities (such as the European Medicines Agency and other authorities) to manage adverse events and to protect public health and ensure high standards of quality and the safety of Bayer Health Products.
Our Pharmacovigilance obligations require us to process certain information, which allow to directly or indirectly identify a person, (“Personal Data”) of a patient and/or the reporter of an adverse event that we receive in order to comply with strict obligations to perform benefit-/risk assessments of Bayer Health Products continuously and report suspected adverse reactions or events to relevant regulatory authorities.
This Pharmacovigilance Privacy Statement (“Statement”) provides important information to you about how we process Personal Data for PV purposes, in line with our obligations under applicable data privacy laws and in particular the EU General Data Protection Regulation ((EU) 2016/679) (“GDPR”).
All Personal Data is processed exclusively for PV purposes and only where relevant and appropriate to document, assess and report your adverse event properly in accordance with our Pharmacovigilance obligations.
If you have any questions about this Statement or about how we use your Personal Data, please contact us via our contact details at the end of this Statement.
We may need to process (includes collecting, storing or otherwise using) the following Personal Data:.
As part of meeting our Pharmacovigilance obligations, we may process Personal Data to:
As part of meeting our Pharmacovigilance obligations, we may share and/or disclose Personal Data:
Our Pharmacovigilance databases are hosted in Germany by Bayer. However, we may need to transfer your Personal Data to other members of the Bayer Group or to third party business partners and regulatory bodies. These may be based outside of the European Economic Area (“EEA”) in a country for which the European Commission has not decided that it ensures an adequate level of data protection (“Third Country”).
Whenever we need to transfer your Personal Data for the PV Purposes to a third party business partner located in a Third Country, we apply standard data protection clauses adopted by the European Commission as appropriate safeguards. You can obtain a copy of them by contacting our Data Privacy Officer using the contact details set out below.
We have implemented appropriate state of the art technical and organisational measures to safeguard Personal Data processed for the PV Purposes, including safeguards and procedures designed to restrict access to Personal Data to those employees who need it to perform their job responsibilities.
We maintain physical, electronic and procedural measures to safeguard Personal Data from accidental loss, destruction or damage and unauthorised access, use and disclosure.
Where reasonably possibly, we process Personal Data in key coded/pseudonymized form.
We will use and store your Personal Data in accordance with mandatory legal requirements governing storage and reporting of Pharmacovigilance related information. Such mandatory requirements oblige us to archive PV information which may include Personal Data at least for the duration of the product life-cycle and for an additional ten years after the respective medicinal product and medical devices has been taken from the market.
Bayer processes PV relevant Personal Data, including special categories of personal data, in accordance with the GDPR
You have the right to:
Please note however, that these rights may be limited in order to fulfil Pharmacovigilance obligations. Your rights are limited where there is a legal ground for processing your Personal Data, for example we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate. We may require you to provide proper identification before we comply with any request to access or correct your Personal Data.
For any questions you may have with respect to data privacy for pharmacovigilance data or data privacy in general, please contact our company data protection officer via email or at the following address:
Data Protection Officer of Bayer Middle East FZE:
Bayer Middle East FZE
Office Park Building Block B, 5th Floor
PO BOX 500829, Dubai, United Arab Emirates
Further and general information about data privacy at Bayer you will find in the Privacy Statement.
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