Almus Post-Marketing Pharmacovigilance Privacy Notice

Effective Date: [25 May 2018] 

I. Information We Collect and How We Use It

• Patients.  We collect and process personal data (including sensitive personal data) about patients who experience actual or suspected adverse events. Personal data about patients may include:
   
• Patient identifiers, including the patient's initials, assigned ID, date of birth, age/age group, gender, weight, height or ethnicity, or a combination of any of the foregoing. We use this information to comply with regulatory obligations to report suspected adverse events and to identify duplicate events and related reports.  
• Health information, including the patient's medical history and health status, and medicinal products taken by the patient. We use this information to comply with regulatory obligations to report suspected adverse events and for effective safety data analysis and surveillance, including to help us understand more about the risks and benefits of a given product and to enhance the safety of patients. 
• Event information, including information about the adverse event or other special safety situation (e.g., pregnancy, breast feeding, overdose, interactions, product abuse/misuse, medication error, unapproved/off-label use, occupational exposure, or lack of therapeutic effect), and other information to describe the course and outcome of the event (e.g., details of symptoms, severity, duration, treatment and what medical attention (if any) was sought). We use this information to comply with regulatory obligations to report suspected adverse events and for effective safety data analysis and surveillance, including to help us understand more about the risks and benefits of a given product and to enhance the safety of patients. 

• Reporters.  We collect and process personal data about reporters of actual or suspected adverse events, such as the patient's healthcare provider, family member, or the patient themselves. Personal data about adverse event reporters may include the reporter's name, occupation or title, address, telephone number, email address, or other contact details. We use this information to comply with regulatory obligations to report suspected adverse events and to perform effective follow-up to ensure that complete and accurate PV data is collected and analyzed (e.g., we may use a reporter's contact information to obtain additional information about the event reported as part of our safety analysis). 

II. How Personal Data is Shared

III. Your Rights

Access Right

• the purposes of the processing;
• the categories of personal data concerned;
• the recipients or categories of recipient to whom the personal data have been or will be disclosed. Where personal data is transferred to a third country or to an international organization, you shall have the right to be informed of the appropriate safeguards pursuant to GDPR relating to the transfer;
• where possible, the envisaged period for which the personal data will be stored or, if not possible, the criteria used to determine that period;
• the existence of the right to request from Almus rectification or erasure of personal data or restriction of processing of your personal data or to object to such processing;
• the right to lodge a complaint with a supervisory authority;
• where the personal data is not collected from you, any available information as to its source; and
• the existence of solely automated decision-making and meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing. 

Right to Rectification 
 

 

Right to Erasure
 

• your personal data is no longer necessary in relation to the purposes for which it was collected or otherwise processed;
• you object to the processing where such processing is based on the legitimate interest of Almus (or a third party) and there are no overriding legitimate grounds for the processing; or
• your personal data must be erased for compliance with a legal obligation in EU or Member State law.  

• compliance with a legal obligation which requires processing by EU or Member State law to which Almus is subject; or
• archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, to the extent permitted under applicable law.

Right to Restriction of Processing

• the accuracy of the personal data is contested;
• the processing is unlawful and you oppose the erasure of your personal data and request the restriction of its use instead;
• Almus no longer needs the personal data for the purposes of the processing, but it is required by you for the establishment, exercise or defense of legal claims; or
• where the processing is based on the legitimate interest of Almus (or a third party) and you have objected to processing. 

 

Right to Object

Right to File a Complaint

IV. How We Protect Personal Data

• Access to personal data is limited to authorized employees and service providers who need access to perform the activities described in this privacy notice on our behalf.
• Personal data is pseudonymized where appropriate or required by law.
• Almus personnel engaged in the processing of personal data are informed of the confidential nature of personal data, have received appropriate training on their responsibilities, and are obligated pursuant to Almus policy to maintain the confidentiality of personal data.
• The effectiveness of Almus security measures are regularly tested, assessed, and evaluated to ensure the ongoing security of processing systems.
• Internet-connected databases containing personal data are monitored for unauthorized intrusions using network-based and/or host-based intrusion detection mechanisms.
• Service providers and other third parties engaged by us to process personal data on our behalf are contractually obligated to process personal data only on our documented instructions and must provide similar security measures as those used by Almus and as required under applicable law. 

V. Retention and Deletion of Personal Data

VI. How to Contact Us

VII. Changes to Our Privacy Notice