PHARMACOVIGILANCE :

The Pharmacovigilance system is the system designed to monitor the safety of the vaccines manufactured by Bio-Med Pvt. Ltd, to promptly reveal all the changes in the evaluation of benefit-risk profile ratio, to develop and implement measures to support the usage of vaccines if the risk level is below the benefit level. The aim of Pharmacovigilance is to enhance patient case and patient safety in relation to the use of vaccines and to support public health program by providing reliable, balanced information for the effective assessment of the risk benefit profile of vaccines. Biomed is continuously evaluating the benefit risk profile as well as safety profile of vaccines. Marketed vaccines are regularly assessed through their life cycle. Marketing Executives are responsible for collection of safety information and reporting the information to Pharmacovigilance department. Where appropriate, Safety information is reported to Regulatory Authority during PSUR Submission or for serious safety concern, reported as soon as possible after such concern are identified. When introducing any changes into Pharmacovigilance system, Bio-Med (P) Ltd informs the regulatory authority and/submits an application on introducing of changes within the terms of appropriate procedures or upon a request of the regulatory Authority. Bio-Med (P) Ltd. has established a specific Pharmacovigilance system for vaccines, and takes appropriate measures including:
• Collecting and record all available information regarding the distribution of vaccines batches.
• Collecting and record all suspected ADR associated with vaccines originating from unsolicit or solicit sources.
• Communicating as an emerging safety concern related to the vaccines that may impact on its benefit-risk profile.
• Continuously maintaining a high level of Preparedness to quickly document and investigate safety issues.
Any Serious Adverse Event reported is handled through our defined procedure (SOP) and necessary corrective action is taken to find the root cause. In case of Adverse events reported, kindly fill up our online form & submitted to our organization.
• If you want to fax this form ,Please Fax us this form
Our Fax No. is 0091- 0120-4340219
• If you prefer to call us,
Dial on 0120-4340219/4157534 / 24 hour Tel No. 9810376421.
E-mail: bmvaccine@yahoo.com.

You can use the FORM below to get in touch with Bio-Med for any questions or comments. We appreciate your interest in our company and would respond to your queries at the earliest. Regards
Bio-Med Team