1. CURRICULUM VITAE
Geetha Madhavi .G
Contact no. : +91 70951 67166
Email id. : geethamadhavi88@gmail.com
Res. Address : D.No.5-1-2, RBR Nilayam, Deepthisreenagar, Madinaguda, Hyderabad -500 050.
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Objective
Seeking a challenging position in pharma, which encourages growth and leadership opportunities
while utilizing technical expertise, innovative abilities and interpersonal skills, consequently
increasing my potential to give my best to the work.
Trained in Pharmacovigilance (Excel Life Tech, Oct-2015 to Dec-2015)
I have undergone extensive training in Pharmacovigilance and familiarized with the following
contents
 Guidelines for Good Clinical Practice (ICH-E6)
 Introduction & Basic concepts of Pharmacovigilance
 Detailed understanding of SAE form & Labelling
 Collection, check for validness, check for duplication, accurate evaluation, data basing and
reporting of adverse events with in timelines
 Processing and Evaluation of non-expeditable AE reports, including review for completeness
and accuracy.
 Seriousness criteria and Causality assessment
 Medical dictionary (MedDRA-18.1) usage for coding medical history and adverse events
 Use of drug dictionaries (ATC DD & WHO DD) for coding drugs
 Preparation of narratives summarizing the essential details of the case.
 Different steps in SAE’s reporting including online and offline medical review and data
reconciliation process
 Preparation of follow up request needed to collect the clinically relevant information missing
from initial case report from the respected sources
 Potential safety signal detection and risk assessment management plan for the cases reported
 Aggregate reports (PSUR’s and DSUR’s)
 Expectedness or Listedness of adverse events
 Awareness on Oracle Argus Safety Database 7.0.6 (Triage, Book-in, Data Entry, Case
Processing, event coding, narrative writing)
01-Jul-2013 to 24-Jun-2015
Asst. Chemist -QA & RA at Smilax Laboratories Ltd.
 Reviewing of quality documents like APQR, stability data, change controls, batch records,
finished product/packaging material data and analytical data for the purpose of compilation of
the dossier
 Handling customer queries related to dossier and coordinating with other departments for the
resolution
 Preparation & submissions of COPP, WHO-GMP application to Regulatory authorities for
India marketing

2. 26-Dec-2012 to 01-Jul-2013
Tr. Chemist - QA at Smilax Laboratories Ltd.
 Vendor evaluation and qualification for starting materials and raw materials
 Ability to handle process validation and cleaning validation protocols and reports
 Preparation of Annual Product quality Review (APQR)
Educational Qualifications
 Master of Pharmacy (2010-2012)
Specialized in Pharmaceutical biotechnology with 9.0 CGPA from University College of
Pharmaceutical Sciences, Andhra University, Visakhapatnam, A.P, India.
 Bachelor of Pharmacy (2006-2010) [Registered Pharmacist by PCI (27-Nov-2014)]
Scored 73.2% from A.K.R.G College of pharmacy (Affiliated by Andhra University),
Nallajerla, A.P, India.
 Intermediate (2003-2005)
Scored aggregate percentage of 85.6% from Sathya Junior College, Machilipatnam, A.P, India.
 S.S.C (2002-2003)
Scored 79.0% from A. B. S. V. Mandir, Machilipatnam, A.P, India.
Areas of Interests: Pharmacovigilance, Pharmacology, Pharmacoepidemiology (Risk management)
Medical writing and Drug regulatory affairs.
Academic Achievement: Secured ALL INDIA RANK 983 in GPAT.
Technical Skills
 MS-Office (Proficient on MS-Word, MS- Excel and Out-look) and Networking
 Knowledge on Chem Draw
 Safety data base Oracle Argus
 Well versed with ICH GCP, GVP, GMP and 21 CFR part 11
Strengths
 Very flexible and adaptable to change
 Hardworking, positive attitude and self confidence
 Can work efficiently as an individual and also co-operative in a team
Personal details:
Date of Birth : 10-05-1988,
Marital Status : Married,
Husband name : B. V. S. N. D. Pavan,
Language Proficiency : Telugu, English and Hindi
Interest : Listening to music, playing chess and updating knowledge
Place: Hyderabad Geetha Madhavi .G