Pharmacovigilance

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. (Reference: WHO)

Department of Pharmacovigilance of Radiant Pharmaceuticals Limited performs all Pharmacovigilance related activities of Radiant Pharmaceuticals Limited, Radiant Nutraceuticals Limited, Radiant Business Consortium Limited, Radiant Export Import Enterprise, Radiant Distributions Limited, Pharmacil Limited, and Jenphar Bangladesh Limited. The pharmacovigilance system of Radiant was set up in 2013. A group of pharmacists is presently working in this department.

Department of Pharmacovigilance maintains separate PV QMS (Pharmacovigilance Quality Management System) to carry out all PV functions including processing ICSRs, monitoring local literature, providing PV awareness training to all employees, communicating & reporting to local Regulatory Authority as well as our Business Partners (F. Hoffmann-La Roche, Boehringer Ingelheim, Cheplapharm, Ferring, Fresenius Kabi, Pfizer, Wockhardt).

What to Report

All Serious & Non-serious Adverse Event (AE) or Adverse Drug Reaction (ADR) related to the use of Radiant’s Products (manufactured, imported and/or distributed) should be reported to the Department of Pharmacovigilance.

Pharmacovigilance

Minimum Information to Report

An adverse event report should contain the four essential information

Patient’s Details

Name / Initials

Gender, age

Contact number

Pregnancy status

Reporter’s Details

Name

Occupation

Address

Contact number

Adverse Event

Date of onset

Symptoms

Outcome

Seriousness

Medical history

Suspected Product(s)

Brand name

Dose, frequency

Route

Batch number

Other medications

An Overview of The Adverse Event Report Form

Download Adverse Event Report Form Download Adverse Event Report Form

All consumers or patients are advised to contact their doctor for advice on medicines or any health problems/ medical emergencies. Pharmacovigilance enhance safer use of medicine by monitoring the safety and efficacy of medicines and by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

Confidentiality Note: Any information related to the identities of the patient and reporter will be kept confidential unless it is subject to disclose due to regulatory obligation.