Galderma India Pvt. Ltd. – Vigilance Privacy Notice
Definitions used in this Privacy Notice
“Adverse event” means an unwanted, unintended or (harmful) – unfavorable event in relation to the use of a Galderma product.
“Personal Data” means data that can be used to identify or contact a single person, either directly or indirectly including but not limited to name, address, e-mail address, user name, telephone number, age, date of birth, gender, education qualifications, posts and other content you submit to our sites, sensitive personal data such as information relating to your health life..
Galderma Vigilance and your privacy
Ensuring your safety is extremely important to Galderma and we take the safe use of all our products seriously. The issue of data protection and confidentiality is a topic we take very seriously by us, and we follow the applicable national and/or European data protection regulations. If you proceed to submit and/or use this website, you are agreeing to abide by this Privacy Notice, without any exceptions.
This Privacy Notice describes how we collect and use your or Personal Data to help us fulfil our legal obligations to monitor the safety of all products we market or have in development. This is known as our Vigilance Obligations. This Privacy Notice also describes how we collect and use your Personal Data when you contact us with general questions about the use of our products.
Scope of this Privacy Notice
This Privacy Notice applies to the information we collect from you by phone, fax, e-mail, post or online as part of the adverse event reporting regulations applicable to Galderma and to the information you submit to us concerning the use of our products or when you visit our website, using various technologies including but not limited to cookies, internet tags and web beacon.
We may also be provided with information about you by a third party reporting of an Adverse event that affected you. Such third parties may include, but not be limited to, health care professionals, lawyers, market research agencies, Galderma sales representatives, relatives or other members of the public.
Information we collect and why we collect it
We collect Personal Data about you when you, or a third party, provide us with information about you in relation to your use of our products or an Adverse event that affected you. The information you provide will be used to answer your queries and enhance our customer service experience. We collect, store and use the information provided by you in strict compliance with applicable laws.
Kindly note that where you are reporting the Adverse event yourself, please also refer to the Reporters section below.
In addition to this, vigilance laws require us to take “detailed records” of every Adverse event passed to us, which allow the event to be evaluated and collated with other Adverse events recorded about that product. The Personal Data that we may collect about you when you are the subject of an Adverse event report and/or when you provide express consent for such Personal Data, to the extent you provide such data includes :
- name or initials;
- age and date of birth;
- weight and height;
- internal reference number;
- details of the product causing the event, including the dosage and duration you have been taking or were prescribed, the reason you have been using the product and any subsequent change to your regimen;
- details of other medicines or remedies you are taking or were taking at the time of the event, including the dosage you have been taking or were prescribed, the period of time you were taking that medicine, the reason you have been taking that medicine and any subsequent change to your regimen;
- details of the adverse event you suffered, the treatment you received for that event, and any long-term effects the event has caused to your health; and
- other medical history considered relevant by the reporter, including documents such as lab reports, medication histories and patient histories.
Some of this information is considered by law to be “sensitive personal data” about you. This includes any of the following categories of sensitive personal data:
- health data;
- official identifier;
- sex life;
- sexual orientation ;
- genetic data;
- transgender status;
- intersex status;
- caste or tribe;;
- any other category of data specified under applicable data protection laws from time to time.
This information is only intentionally processed where relevant and necessary to document properly the event that occurred to you and for the purpose of meeting our vigilance requirements. These requirements exist to allow us and competent vigilance authorities to diagnose, manage and prevent such adverse events from occurring in the future. We may also incidentally collect your sensitive Personal Data if you volunteer it to us.
We understand the importance of taking extra precautions to protect the privacy and safety of children using Galderma’s products and services.
If you are under the age of 18, you must first tell your parent or legal guardian that you wish to register on our digital platforms and get their consent. You must make sure that your parent or legal guardian knows and agrees each time before you:
- email us, or ask us to email anything to you;
- send any information to us or
- offer or agree to buy anything online.
Once we receive appropriate authorization or consent from your parents or legal guardian, we may collect your date of birth and retain that with your name and other details you may provide. This is so we can ensure we treat you in an age appropriate way in line with this Privacy Notice.
For so long as you are under the age of 18 we will not send you any marketing communications, allow you to access any of our digital platform message boards, or share your details with our partners. However, if you have signed up to receive a product or service we may contact you about this.
If you report an Adverse Event to us, either concerning yourself or a third-party, we are required to collect your Personal Data to ensure that Adverse Events are traceable and available for follow-up. As a result, we must keep sufficient information about reporters to allow us to contact you once we have received the report. The Personal Data that we may collect about you when you report an Adverse Event shall include, but not be limited to, is your:
- contact details (which may include your address, e-mail address, phone number or fax number);
- profession (this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); and
- relationship with the subject of the report.
Where you are also the subject of a report, this information may be combined with the information you provide in relation to the event that occurred to you.
As part of meeting our vigilance obligations, we share your information with our offices in Switzerland, France and Sweden to meet our legal requirements to review patterns across every country where we market our products. In particular, we may use and share your information:
A) For purposes which are required by law:
· to investigate the Adverse event;
· to collate the information about the Adverse event with information about other Adverse Events received by Galderma to analyse the safety of a batch, Galderma product or active ingredient as a whole; and
· to provide mandatory reports to national authorities or other public authorities so that they can analyse the safety of a batch, Galderma product, generic or active ingredient as a whole alongside reports from other sources.
B) Where you give your consent:
· to contact you for further information about the Adverse Event you have reported; and
· to respond to any questions you may have concerning your use of our products.
. to provide newsletters, articles, alerts, information about products, brand, and related topics.
C) Where this is necessary for purposes which are in our, or third parties, legitimate interests. These interests are limited:
· to analyse and improve our products; and
· to review and monitor the quality of our customer service.
We also use and share your Personal Data in the course of responding to any questions or concerns you may have concerning your use of our products, such as if you enquire about what to do if you did not adhere to the product's dosage requirements.
In addition, we may share your Personal Data with third party service providers. These are external companies that we use to help us run our vigilance activities. Service providers and their selected staff are only allowed to access and use your Personal Data on our behalf for the specific tasks that they have been requested to carry out, based on our instructions and are required to keep your Personal Data confidential and secure.
Personal Data collected from you may also be transferred to a third party in the event that one of our products is sold, assigned or transferred, in which case we would require the buyer, assignee or transferee to treat that Personal Data in accordance with applicable data protection laws and/or regulations.
We share information so collected with national authorities in accordance with pharmacovigilance laws or industry codes.
The storage as well as the processing of your personal data as described above may require that your Personal Data are ultimately transferred/transmitted to, and/or stored at a destination outside of your country of residence, in accordance with the prevalent data protection laws and/or regulations.
We may provide links to other websites, which we believe, may be of interest to you. We shall not be responsible for the content of such other websites and we shall not be responsible for the information shared by you on such websites, under any circumstances whatsoever.
How we store information
Because patient safety is so important, we retain all the information we gather about you as a result of an adverse event report or a query regarding a Galderma product to ensure that we can properly assess the safety of our products over time. To protect your privacy, when processing and transferring the data, we put in place measures to reduce the ability of the data to be linked back to you by pseudonymizing the data.
We retain vigilance reports for the retention periods required under applicable laws. Where we are not required by law to retain your Personal Data, we will keep your data only for as long as we need to for the specifc purpose collected, to respond to any follow up questions you may have or to analyse and improve our products, after which we take steps to remove the Personal Data from our systems. We may be required to retain your Personal Data for a longer period of time if such retention is explicitly mandated, or necessary to comply with any obligation, under a law. We shall, whenever possible, endeavour to anonymise the information or remove the identifiers from our records that we may be required to retain beyond the original retention period.
Your rights in relation to your Personal Data
We respect your right to access and control your information, and we will respond to requests for information and, where applicable or appropriate, will correct, amend, or delete your Personal Data. In order to protect your privacy, we will take reasonable steps to verify your identity before granting access to your Personal Data. In such cases, we will need you to respond with proof of your identity before you can exercise the rights mentioned below :-
- You may ask Galderma for a copy of your Personal Data, to correct/update it, erase or restrict its processing, or to ask us to transfer some of this information to other organisations.
- You may also have rights to object to some processing and where we have asked for your consent to process your data, to withdraw this consent.
- You also have the right to tell us if you: (i) don't want to be contacted in the future by us or (ii) wish to report any misuse of your Personal Data.
These rights may be limited where we can demonstrate that we are unable to comply with your request. For example, for legal reasons we cannot delete information that has been collected as part of an adverse event report, unless it is inaccurate.
Where we require Personal Data to comply with the legal obligations, then provision of such data is mandatory: if such data is not provided, then we will not be able to meet our reporting obligations. In all other cases, provision of requested personal data is optional.
We hope that we can satisfy queries you may have about the way we process your Personal Data. If you have any concerns about how we process your Personal Data and/or if you want us to address any grievance you may have regarding the same, please contact our Group Data Protection/Grievance Officer at [email protected] if you have unresolved concerns. You also have the right to complain to data protection authorities.
Your data are submitted to Galderma India Pvt. Ltd. and in addition to being stored in databases in Galderma India Pvt.Ltd. are hosted and stored in databases on servers situated in Switzerland, which are owned and maintained by Galderma S.A., a Swiss limited liability company whose principal place of business is at:
Rue d’Entre-deux-villes 10,
1814 La Tour de Peilz,
We may change our Privacy Notice from time to time and post the updated version of the same. We encourage you to visit frequently to stay informed about how we use your Personal Data.
Notice effective July 2020
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