Anil Kumar.
Aleti
Mobile: 91-9164780319, 9966997847
Email: anil.pharmaco@yahoo.co.in
OBJECTIVE:
To secure a challenging position in the organization and to excel as a successful employee in the
organization and to strive for the growth of it by becoming the part of the team with hard work
and commitment.
PROFESSIONAL EXPERIENCE:
1) Working as Senior Drug Safety Associate at Quintiles Technologies Pvt. Ltd., for Johnson
& Johnson from January2013-till date.
Roles & Responsibilities:
Key roles and responsibilities as a Drug Safety Associate:
Review, assess, triage, process and report the adverse event reports according to
applicable regulations, guidelines, SOPs and project requirements with in the specified
time lines by meeting the quality standards.
Ensure a duplicate check is conducted against the Global Safety Database in accordance
with SOPs for all ICSRs (Individual Case Safety reports) in order to determine whether
there is an existing case file.
Creating an electronic case report file for a new case.
Assessment of case reports for seriousness, case validation, causality and expectedness.
Prioritizing the adverse event reports processing based on the ICH dates.
Perform safety data entry in the database, coding relevant medical terminology, writing
descript narratives, generating queries pertinent to the case, performing quality control
and ensure case reporting.
Coding of medical history, drugs and reported adverse event terms in safety database
using medical dictionaries like MedDRA, and WHO-DRL.
Filing PQCs (product quality complaints) associated with adverse events.
Performing quality review (serious and non-serious cases) and checking cases for
discrepancies for any errors related to labeling and narrative writing.
Setting up follow-up letter to the reporter for further case follow-up as per the applicable
guidelines and reporting the case to the respective regulatory agencies.
Attend project team meetings and client calls related to the project and provide feedback
to operations manager on any challenges/issues or successes.
1) Pharmacovigilance Trainee
Gratisol Labs, Hyderabad, April 2012 – October 2013.
I have undergone rigorous training in Oracle Argus Safety Database 6.0, with Pharmacovigilance
foundation and have experience of processing cases.
Roles & Responsibilities:
Case assessment
Duplicate check and case initiation
MedDRA coding
WHO DD coding
SAE narrative writing
Expectedness or Listedness of adverse event
Domain Skills:
Clinical Research& Pharmacovigilance Domain Awareness.
Knowledge on drug development (Phase I -IV) of clinical trial.
Pharmacovigilance in India.
Adverse events and it’s reporting standards.
Adverse events reporting forms.
Expedited case and it’s reporting time lines.
Hand on experience on Oracle Argus Safety 6.0 Database - Data Entry,
Case Processing MedDRA coding, SAE narrative writing of more than 30 cases.
2) Krishna Institute of Medical Sciences, Minister Road, Hyderabad (KIMS)
Conducted drug information in clinical department of KIMS.
Performed patient counseling on various drug –interactions, adverse drug reactions, non
Pharmacological treatment
SKILLS:
Database : Oracle Argus Safety Database 6.0
Office Tools : MS Word, Excel, Power Point
Operating System : Windows-xp,windows7
Dictionary : MedDRA 14.0 & WHO Drug.
EDUCATION:
DOCTOR OF PHARMACY (PHARM.D)
Bharat College of Pharmacy, Ibrahimpatnam, Hyderabad, India
Major: Therapeutics, Clinical Pharmacy.
Relevant Courses: Pharmacokinetics and Pharmacodynamics, Clinical Research and Toxicology,
Pharmacoepidemiology, Biostatistics, Hospital Pharmacy.
Project Title: A prospective comparative study on the efficacy and safety of Amisulpride and
Risperidone in the patients of schizophrenia.
BACHELORS OF PHARMACY [Oct 2005-May 2009]
Holy Mary Institute of Technology and Sciences, Hyderabad, India
Project Title: Antidepressant activity profile of ethanolic extract of Portulaca olaracea l.
Relevant courses: Pharmaceutics, Pharmacokinetics, Pharmaceutical Analysis, Biotechnology,
Pharmacology, Pharmaceutical Engineering, Microbiology
HIGHER SECONDARY EDUCATION from Sri Chaitanya Junior College from Board of
Intermediate Education, Hyderabad, A.P (2002-2004).
SSC from St Thomas Convent High School, Nirmal A.P (2002) from State Board of Education.
Areas of Interest:
Pharmacovigilance
Clinical Research
Clinical Pharmacist.
Extra Curricular Activities:
Won first prize in table tennis (single’s) inter-college competition held at HITS Group of
Institutions
Won second prize in volley ball inter-college competition held at HITS Group of
Institutions.
Performed as student coordinator for Holy Mary Institute of Technology and Sciences
college fest (PHARMACASO- 09)
Lead the college cricket team as a captain in inter-college competitions organized by
JNTU-H
PERSONAL DETAILS:
Date of Birth : 21st July1987
Father Name : A.Rukma Reddy
Permanent Address : H.No-2-3-31/1,
Fort house apts, Flat no-102,
6no X Roads, Baghamberpet,
Hyderabad-500013.
Sex : Male
Nationality : Indian
Languages Known : English, Telugu, and Hindi.
REFERENCES:
1) Dr. A Shekar Reddy MBBS, DPM, FIPS
Consultant Psychiatrist (KIMS Hospital, Hyderabad)
Phone: +91:9247116640, 9848059452
2) Dr. Sidharth Mathur., PGDCC, DCMRD
Consultant Cardiologist (Mahavir Hospital - Hyderabad),
Phone: +91-9849297828
3) N.Aravindakshan Nayar
Position: General Manager
Sri Krishna Drugs and Pharmaceuticals Ltd (Hyderabad).
Email id: aravi111@rediffmail.com.
Phone number: +91-9866542422
DECLARATION:
I do hereby declare that the particulars of information and facts stated here in above are true,
correct and complete to the best of my knowledge and belief.
Date:
Place: A.Anil Kumar.
