Pharmacovigilance

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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 Klarris Pharmaceuticals Pvt. Limited performs all Pharmacovigilance related activities of Klarris Pharmaceuticals Pvt. Limited, Klarris Nutraceuticals Limited, Klarris Business Consortium Limited, Klarris Export Import Enterprise, Klarris Distributions Limited and Pharmacil Limited. Pharmacovigilance system of Klarris was set up in 2020. A group of doctors and pharmacists are presently working at 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.


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.

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 Products


Brand name
Dose, frequency
Route
Batch number
Other medications

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