EEA and Swiss Safe Harbor Privacy Guidelines

GENERAL:

PharmaVigilant is committed to the privacy and security of its customers, employees, consumers, business partners and others. PharmaVigilant operates under a set of strict privacy principles, and strives to gather, use and disseminate personal information in accordance with the laws of the countries in which it does business. This Safe Harbor Privacy Policy (the "Policy") discloses the privacy principles PharmaVigilant follows with respect to transfers of personal information from the from the European Economic Area ("EEA") and/or Switzerland to the United States of America.

The United States Department of Commerce and the European Commission have agreed on a set of data protection principles and frequently asked questions concerning the collection, use, and retention of personal information from European Union member countries (the "U.S.-EU Safe Harbor").  The United States Department of Commerce and the Federal Data Protection and Information Commissioner (FDPIC) of Switzerland have agreed on a similar set of principles and frequently asked questions concerning the transfer of personal data from Switzerland to the United States (the "U.S.-Swiss Safe Harbor").  Accordingly, PharmaVigilant adheres to the principles set forth in the U.S.-EU Safe Harbor and the U.S.-Swiss Safe Harbor (the "Safe Harbor Principles").  PharmaVigilant has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement.  To learn more about the Safe Harbor program, and to view our certification page, please visit http://www.export.gov/safeharbor/.

SCOPE:

This Safe Harbor Privacy Policy (the "Policy") sets forth the privacy principles PharmaVigilant follows with respect to any transfer of personal data from the EEA and/or Switzerland to the United States. The Policy applies to all personal data received from the EEA and Switzerland by PharmaVigilant whether in electronic, paper or verbal format.

Please note that PharmaVigilant provides its clients with services that involve it processing personal data on its client's behalf, for instance where it supplies system trouble-shooting, data warehousing and application management services. In this capacity, PharmaVigilant's client owns and controls the personal data it processes. PharmaVigilant receives and processes personal data merely as a "data processor" on behalf of its client. As a data processor acting on behalf of a PharmaVigilant client, PharmaVigilant is not required to comply with the these principles but is required to perform its services in accordance with its contract with the client concerned and any data privacy protections incorporated therein. This Policy is to be read subject to this distinction.

DEFINITIONS:

For purposes of this Policy, the following definitions shall apply:

"Agent" means any third party that collects or uses personal information under the instructions of, and solely for, PharmaVigilant or to which PharmaVigilant discloses personal information for use on PharmaVigilant's behalf.

"PharmaVigilant" means PharmaVigilant, Inc., its predecessors, successors, subsidiaries, divisions and groups in the United States.

"Personal information" means any information or set of information that identifies or could be used by or on behalf of PharmaVigilant to identify an individual. Personal information does not include information that is encoded or anonymized, or publicly available information that has not been combined with non-public personal information.

"Sensitive personal information" means personal information that reveals race, ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, views or activities, that concerns health or sex life, information about social security benefits, or information on criminal or administrative proceedings and sanctions other than in the context of pending proceedings. In addition, PharmaVigilant will treat as sensitive personal information any information received from a third party where that third party treats and identifies the information as sensitive.

CHOICE:

PharmaVigilant will provide individuals an opportunity, at any time, to choose (through an 'opt out' choice) whether their personal data is to be disclosed to a non-agent third party, or used for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.  For sensitive personal information, PharmaVigilant will give individuals the opportunity to affirmatively or explicitly consent (through an 'opt in' choice) to the disclosure of the information to a non-agent third party or the use of the information for a purpose other than the purpose for which it was originally collected or authorized by the individual.

DATA INTEGRITY:

PharmaVigilant will only process personal data in a way that is compatible with and relevant for the purpose for which it was collected or authorized by the individual. To the extent necessary for those purposes, PharmaVigilant will take reasonable steps to ensure that personal data is accurate, complete, current and reliable for its intended use.

TRANSFER TO AGENTS:

PharmaVigilant will obtain assurances from its agents that they will safeguard personal information consistently with this Policy. Reasonable steps will be taken by PharmaVigilant if an agent is using or disclosing personal information in a manner contrary to this Policy.

ACCESS:

PharmaVigilant will grant an individual access to their personal data upon request and will provide reasonable measures to allow the correction, amendment or deletion of inaccurate information, except where the burden or expense of providing access would be disproportionate to the risks to the privacy of the individual in the case in question or where the rights of persons other than the individual would be violated.

DATA SECURITY:

PharmaVigilant takes all reasonable security measures to protect against the loss, misuse, alteration and destruction of the information under our control.

ENFORCEMENT AND DISPUTE RESOLUTION:

PharmaVigilant encourages interested persons to raise any concerns using the contact information provided below and it will investigate and attempt to resolve any complaints and disputes regarding use and disclosure of personal information in compliance with the Safe Harbor principles:

PharmaVigilant Privacy Office
PharmaVigilant., Inc.
Suite #308
69 Milk Street
Westborough, MA 01581
Phone: 508-898-0018
Email: PharmaVigilant Privacy Office

If a complaint or dispute cannot be resolved through our internal process, PharmaVigilant agrees to use an independent dispute resolution mechanism, the BBB EU SAFE HARBOR, operated by the Council of Better Business Bureaus. If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed by PharmaVigilant, you may contact the BBB EU SAFE HARBOR program at the address below:

Council of Better Business Bureaus, Inc.
BBB EU SAFE HARBOR
4200 Wilson Boulevard, Suite 800
Arlington, VA 22203
Phone:  703-276-0100
Web: www.bbb.org/us/safe-harbor-complaints

CHANGES TO THIS SAFE HARBOR PRIVACY POLICY: 

This Policy may be amended from time to time, consistent with the requirements of the Safe Harbor Principles.  We will post any revised policy on this website (www.pharmavigilant.com).

EFFECTIVE DATE: April 2011