The document provides a summary of Shalini P's career objective, clinical research and pharmacovigilance knowledge, academic credentials, project work experience, and work experience. Her objective is to work for an organization that allows her to improve her knowledge and skills while contributing to the organization's growth. She has extensive knowledge of clinical trials, drug development, pharmacovigilance, and medical terminology. She has a Diploma in Clinical Research & Pharmacovigilance and an M.Pharmacy degree. Her work experience includes roles in quality assurance and as an analyst in quality control and quality assurance.

1. SHALINI.P______________________________________
Career Objective:
To be associated with an organization, which progress dynamically, and gives me a chance
to improve my knowledge, to enhance my skills and to be part of team excellence in works
towards the growth of the organization.
Clinical Research & Pharmacovigilance Knowledge:
• Has very good knowledge on ICH GCP guidelines.
• Has very good Knowledge on Clinical trials and Drug Development.
• Has very good knowledge on pharmacovigilance and drug safety
• Has very good knowledge on MedDRA and Medical Terminologies
• Has knowledge on signal detection & risk management.
• Has knowledge on Serious Adverse Events (SAE) reporting guide lines
• Has knowledge on writing narrative summaries and concomitant medications on
reported adverse event cases.
• Has very good knowledge on Pharmacology and Pharmacotheurapetics, Anatomy and
Physiology.
• During the course, very well understood the protocol and content of the protocol like
visit structure, procedures, therapeutic area and randomization especially which is
applicable to develop database.
• Has knowledge on CRF (Case report form) entry & Query resolution.
• Successfully learned industry based training to design paper CRF from the protocol.
ACADEMIC CREDENTIALS:
EXAMINATION
PASSED
BOARD/
UNIVERSITY
INSTITUTE YEAR OF
PASSING
PERCENTAGE
Diploma in
Clinical Research &
Pharmacovigilance
Private NOMAD Life Sciences Pvt.
Ltd, Hyderabad
2016 A+ Grade
M. Pharmacy
(Pharmaceutical
Biotechnology)
JNT University JNT University, Hyderabad 2014 75%
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2. B. Pharmacy JNT University Shadan College of
Pharmacy
2007 70%
Project Work (During M. Pharmacy & B. Pharmacy):
• Analytical validation of LANSOPRAZOLE Drug
• Analytical Method Development & Validation of OLANZEPINE in pure and
Pharmaceutical Dosage Form
Work Experience:
JAN – 2010 to MAY- 2014: Executive QA, Vivimed Labs Ltd
Responsibilities:
• Management of Document Issue, Review and Retrieval.
• Preparation of Annual Product quality Review.
• Co-ordination in QA Systems (Change control, Deviation)
• Preparation and Review of SOP’s and its implementation.
• Dispatch activities.
• Maintain the Retention samples.
• Daily process audits and internal quality checks.
• Conducting training program on SOP’s.
• Document control.
May-2007 to Dec-2009: Analyst QC& QA, Legend Drugs and Formulations Pvt.Ltd,
Hyderabad.
Responsibilities:
• Responsible for all In-process Quality Assurance checks during Manufacturing
Operations and packing operations
• During the production of tablets checking the physical parameters.
• Preparation of COA’S
• Responsible for carrying out the calibration of instruments as per schedule.
• Batch Production record review & Retrieval
• Preparation and Review of SOP’s and its implementation.
• Return goods handling.
• Dispatch & IPQA activities.
• Maintain the Retention samples.
Training Programs Attended:
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3.  CGMP training programs.
 ISO training programs for internal auditing
Computer Proficiencies:
• Ms office
• Windows Xp/2000/7
Language(s) Known:
Language(s) Read Write Speak
English √ √ √
Hindi √ √ √
Telugu √ √ √
Personal Details:
Date of Birth: 10-Jul-1986
Gender: Female
Contact no. : +91-9154637444
Email: p.shalinireddys@gmail.com
Address:
H.No: 49-374/1/1/A
Balreddy Nagar
Chintal,Hyderabad.
Andhra Pradesh – 500055
Declaration:
I hereby declare that above information is true to the best of my knowledge & nothing has
been concealed herein. All the documents in original/attested copy will be produced
whenever required.
PLACE: Hyderabad SHALINI.P
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