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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