PiONEER Pharmaceutical Industries
1. Purpose of this Privacy Notice
PiONEER Pharmaceutical Industries is committed to protecting the confidentiality and privacy of personal information received in connection with the safety and quality of its medicinal products.
This Privacy Notice explains how PiONEER may collect, use, retain and, where necessary, disclose personal information when you:
- report an adverse event or adverse drug reaction;
- report a special situation related to the use of a PiONEER medicinal product;
- provide follow-up safety information;
- request medical information about a PiONEER product; or
- submit a product quality complaint.
This Privacy Notice also applies to individuals whose information is included in such reports, including patients, healthcare professionals, caregivers and other reporters.
2. Why Do We Collect and Use Personal Information?
PiONEER may process personal information for the following purposes:
Drug Safety Monitoring
To monitor and evaluate the safety of PiONEER medicinal products, including:
- receiving and documenting adverse event and adverse drug reaction reports;
- assessing reported safety information;
- conducting follow-up when additional information is required;
- identifying and evaluating potential safety issues or signals;
- monitoring special situations related to medicinal product use;
- fulfilling pharmacovigilance and regulatory reporting obligations; and
- taking appropriate measures to protect patients and public health.
Special situations may include, where applicable:
- exposure during pregnancy or breastfeeding;
- medication errors;
- overdose;
- misuse or abuse;
- off-label use;
- occupational exposure;
- lack of therapeutic efficacy;
- suspected transmission of an infectious agent through a medicinal product; and
- other clinically relevant circumstances associated with the use of a PiONEER product.
Medical Information
To respond to questions regarding PiONEER medicinal products, including questions related to indications, availability, dosage and administration, formulation, stability, interactions, safety information and other medically relevant information.
Product Quality Complaints
To investigate complaints or concerns relating to the quality, packaging, appearance, stability, performance, effectiveness, safety or use of PiONEER medicinal products.
Regulatory and Compliance Requirements
To comply with applicable laws, Ministry of Health requirements, pharmacovigilance obligations, company procedures, inspections, audits and other regulatory or legal requirements.
Where personal information is necessary for pharmacovigilance or other regulatory obligations, PiONEER may be required to retain and process certain information as necessary to meet those obligations.
3. What Personal Information May We Collect?
The type of information collected depends on the nature of the report or request.
Information About the Reporter
PiONEER may collect information such as:
- name or initials;
- profession or healthcare-professional status;
- place of work;
- telephone number;
- email address;
- relationship to the patient; and
- other contact information necessary to communicate with the reporter or obtain follow-up information.
Information About the Patient
Only information reasonably necessary for evaluation of the report will be collected. This may include:
- initials or other appropriate patient identifiers;
- age or date of birth;
- sex;
- weight and height, where relevant;
- pregnancy or breastfeeding status;
- relevant medical history;
- relevant laboratory or examination results;
- underlying diseases or medical conditions;
- concomitant medications;
- information regarding the suspected medicinal product;
- description and outcome of the adverse event;
- treatment provided for the adverse event; and
- other health information necessary to medically assess the case.
PiONEER aims to collect only the information required to appropriately evaluate, document, follow up and report the case.
4. How Is the Information Used?
Personal information received through PiONEER pharmacovigilance and product-safety channels may be used to:
- create and maintain safety reports;
- medically evaluate adverse events and other safety information;
- contact reporters for clarification or follow-up;
- detect and assess potential safety concerns;
- conduct aggregate safety assessments;
- prepare regulatory safety reports;
- respond to requests from competent health authorities;
- investigate product quality complaints;
- respond to medical information requests;
- support pharmacovigilance audits or inspections; and
- meet applicable regulatory and legal requirements.
Personal information collected for these purposes will not be used for promotional or marketing activities.
5. Who May Have Access to Personal Information?
Access to personal information is restricted to authorized personnel who require the information for legitimate pharmacovigilance, medical, quality, regulatory or legal purposes.
Personal information may also be disclosed to competent health authorities or other parties where required to fulfil applicable legal, regulatory or pharmacovigilance obligations.
6. Confidentiality and Security
PiONEER takes appropriate organizational and technical measures to protect personal information against unauthorized access, inappropriate disclosure, accidental loss, alteration, misuse or unauthorized destruction.
Access to pharmacovigilance information is limited to authorized personnel according to their responsibilities.
Adverse event reports and associated information are treated as confidential safety information.
7. How Long Do We Keep Personal Information?
PiONEER retains pharmacovigilance, medical-information and product-quality information for the period required to:
- appropriately investigate and evaluate the report;
- conduct necessary follow-up;
- maintain the safety history of the medicinal product;
- comply with pharmacovigilance record-retention requirements; and
- meet applicable regulatory and legal obligations.
Information will not be retained longer than necessary except where continued retention is required for pharmacovigilance, regulatory, legal or public-health purposes.
8. Questions or Concerns About Your Personal Information
If you have any questions or concerns about how personal information provided for pharmacovigilance purposes is handled, or if you believe that information held by PiONEER is inaccurate or incomplete, you may contact the PiONEER Pharmacovigilance / Drug Safety Department.
Certain pharmacovigilance information may need to be retained where required to meet applicable regulatory, patient-safety or legal obligations.
9. Reporting an Adverse Event
You may report any suspected adverse event, side effect or other safety concern related to a PiONEER medicinal product directly to PiONEER.
PiONEER Pharmacovigilance / Drug Safety
PV Mobile: 07716427666
PV Email: pv.drugsafety@pioneerpharma.org
Providing complete information, where available, helps PiONEER appropriately evaluate and follow up the report.
You do not need to be certain that the medicine caused the event before reporting it.
10. Questions About This Privacy Notice
For questions regarding the handling of personal information associated with adverse-event reports, medical-information requests or product-quality complaints, please contact:
PiONEER Pharmaceutical Industries
Pharmacovigilance / Drug Safety Department
PV Mobile: 07716427666
PV Email: pv.drugsafety@pioneerpharma.org
Effective Date: [SEP/2026]
