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Tech Trainer - ManjunathKN (5y - 0m)

Manjunath K N is a professional in Pharmacovigilance with experience in managing Individual Case Safety Reports and ensuring compliance with international drug safety regulations. He has worked in various roles related to quality and clinical data analysis and holds a Bachelor of Pharmacy degree. His skills include proficiency in MS Office tools, strong communication abilities, and a commitment to quality in clinical study data review.

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24 views4 pages

Tech Trainer - ManjunathKN (5y - 0m)

Manjunath K N is a professional in Pharmacovigilance with experience in managing Individual Case Safety Reports and ensuring compliance with international drug safety regulations. He has worked in various roles related to quality and clinical data analysis and holds a Bachelor of Pharmacy degree. His skills include proficiency in MS Office tools, strong communication abilities, and a commitment to quality in clinical study data review.

Uploaded by

dishhahrservices
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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MANJUNATH K N

H.No.1726, Omkar Building 6th Main ‘D’ Block 2nd Stage,


Rajaji Nagar Banglore – 560010.
Email: manjunath.hrrvid@gmail.com
Mobile: +91-8548818992.

Career Objective:

 Seeking a challenging career in the field of Pharmacovigilance which needs a high level
knowledge base in health care that extracts the fullest from my professional knowledge and
also helps the recruiting company to grow more in the field with high efficiency to attain a
position in the market, such that my presence will be inevitable in the organization.

Summary:

 Accurate processing of Individual Case Safety Reports, case processing activities by using data
base and comprehensive knowledge of international drug safety and Pharmacovigilance
principles with relevant ICH-GCP guidelines and safety reporting regulations.
 In-depth knowledge of performed Quality /Regulatory Affairs and WHO-Drug dictionaries.
 Hard work & Ability to survive in any type of condition. Positive attitude and approach with
good communication and presentation skills.
 Working knowledge of MS Word, MS Excel, MS PowerPoint.
 Organizational skills and management abilities.

Project Work:

 In Anglo French Drug Pharmaceutical Industries the Name of Project is Formulations and
Evalution of “ANTI INFLAMMATORY DRUGS”.
Professional experience:

 Worked at Med Life International Private Ltd., as Executive QUALITY &


REGULATORY ANALYST from 14-July-2017 To 10-Sep-2018
 Worked at HCG Private Ltd., as Quality & Clinical Data Analyst from
24-Oct-2018 To 19-Jan-2020

Presently Working In Chemikart.

Roles and responsibilities

 Management of Individual Case Safety Reports (ICSRs)


 Receive information on adverse events, perform initial check, duplicate check and follow up
check.
 Ensured accuracy of coding adverse events, medical history, drug indications and lab data by
using MedDRA (Medical Dictionary for Regulatory Activities) dictionary.
 To perform labeling, causality and assess relationship as per the cases.
 Responsible for writing case narratives and processing case-related information.
 To evaluate case information for medical completeness. Generating queries pertinent to the
case.
 Upgrade Non-Serious case to a serious case, following the medical assessment.
 To keep check on regulatory timeline for ICSR submissions and their requirements.
 Perform Quality control of case reports and ensure quality of data through quality control
process.
 To perform initial triage of the received safety notification.
 To follow up ICSRs with the reporter and handle technical product complaints.
 Attending several meeting related to product safety.

Quality Check

 To review the medically relevant safety narrative of cases and check the completeness and
accuracy of the data entered in the various fields.
 Quality reports preparation, tracking of Quality of project and working on plans to meet client
quality expectations.
Roles and responsibilities

 Review of SAE reports and protocols.


 Review of clinical safety reports.
 Responsible for review of patient case narratives.
 Review of clinical study related data.
 Review of clinical study reports.

Academic profiles:

 Bachelor of Pharmacy (B. Pharmacy) with an overall aggregate of 68.34% Rajiv Gandhi
University of Health Science Davangere.
 Diploma in Pharmacy (D. Pharmacy) with an overall aggregate of 71% with distinction from
Rajiv Gandhi University of Health Science Davangere.
 Higher Secondary Education from S.J.V.P College with 43.83%
 SSCL from Mariya Nivas High School with 57.66%

Honors:

 Achieved appreciation award for the outstanding quality and quantity performance for
reviewing clinical study data at HCG Pvt Ltd.,

Skills

 Office Tools : MS Word, Excel, Power Point, DTP,

Achievements:

 Completed the Certificate Course Training Program in Sahydari Narayana Multi


Specialty Hospital Out Patient and Inpatient pharmacy as a part of fulfillment as per the
regulation of ‘DRUG CONTROL DEPARTMENT’.
Personal details:

Name : Manjunath K N
Father name : Ningappa
Date of Birth : 13-12-1991
Sex : Male
Marital status : Unmarried
Languages Known : English, Kannada & Hindi
Nationality : Indian

Declaration:

I hereby declare that the above written particulars are true to best of my knowledge and belief.

Date:
Place: Banglore.
(Manjunath K N)

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