Priyanka Patel is applying for a position in pharmacovigilance. She has over 7 years of experience in pharmacovigilance and quality assurance. Currently, she works as a Junior Data Analyst/Medical Safety Specialist at Cognizant Technologies Solutions, where she performs case processing, quality checking, medical coding, and ensures regulatory reporting requirements are met. Previously, she worked as a Pharmacovigilance Scientist at Tata Consultancy Services and in quality assurance at Pfizer Production Plant. She has expertise in Good Clinical Practice and skills in communication, problem solving, and training.

1. PRIYANKA PATEL
Permanent address:
Shree Sai Samarth housing Co-operative Soc
Kurar Village Malad (East)
Mumbai 400097
Mail Id:priyanka.patel1688@gmail.com
Mobile No: 9833803824
Landline:022-28493299
CAREER OBJECTIVE
To work in an esteemed organization where I can prove, improve and acquire further
knowledge in accordance with the latest trends in pharmacovigilance and work in a team
that progressively works towards the growth and development of the company.
SUMMARY
.
 Presently working in Cognizant Technologies Solutions as Junior Data
Analyst/Medical Safety Specialist from Apr 2014 having a total experience of 3
years in Pharmacovigilance
 Worked in Tata Consultancy Services - Mumbai for a period of 1.5 years as
Pharmacovigilance Scioentist level 1
 Involved in end point adjudication process, handling triaging, safety database
entry, writing narratives, QC, and driving case closure and SAE reconciliation
activities.
 I have managed training of new hires, mentoring, work allocation, communication
with global leads, communicating issues of concern to the functional managers and
discussion with the team regarding errors and preventive action.
 Familiarity with Good Clinical Practice (GCP) and guidelines.
WORK EXPERIENCE
PRESENT
 COGNIZANT TECHNOLOGIES SOLUTION, Current Job Profile – Junior Data
Analyst/Medical Safety Specialist.
 Date of Employment – 02 Apr 2014 to Present

2. KEY RESPONSIBILTIES:
 Processing and Quality check of Post marketing cases to verify accuracy,
consistency, and compliance with process requirements.
 Make Sure that all the event are captured from the case and appropriately
labelled, narrative in chronology with all the suspects drug being captured.
 Perform reviewing medical coding of the events and Drugs data using CDD,
WHODD and MedDRA.
 Determine if appropriate case follow-up has been considered. Conduct follow-up
activities when needed.
 Ensure timely and accurate case review to meet Client and regulatory reporting
requirements.
 Identify any additional queries for any missing data or clarification and document
appropriately in the global safety database with a brief description of the
additional information needed.
 Promote teamwork within the team. Communicate and proactively share
information with the team.
 Understand and work to the current SOPs and ensuring deviations are
documented appropriately.
 Quality review of the ICSR’s (Serious and Non serious) and providing the
appropriate feedback to the associates.
 Awarded with WOW awards (Outstanding performance, productivity and dedicated
service).in 2014 and SPOT OF THE MONTH in 2015
 Awarded with OPEL (High Outstanding performance, Training to new joiners) in
quarter 1 in 2015
PAST
 To work on tool ARISg.
 To work with clinical, spontaneous, Non-interventional Study and Non-
interventional program cases.
 Accountable for handling ICSRs disposition of valid items into ARISg from
IRT for further processing in ARISg (case initiations).
As Pharmacovigilance Scientist level I (From Oct 2012 to Apr 2014)- TATA
CONSULTANCY SERVICES, ROCHE

3.  Acknowledging receipt of ICSRs to sender within the timelines documented
in the relevant SOP.
 Accountable for sending queries for clarity associated with incoming
information if required.
 Handling invalid items in IRT appropriately through reference to SOPs,
relevant training and the ARIS user manual.
 Accountable for performing accurate data capture for individual case safety
reports which can be spontaneous, clinical, NIP and NIS cases.
 Accountable for performing the appropriate clinical assessments (including
the assessment of seriousness, labeling and company causality for each
adverse event) adhering to SOPs/other controlled documents and regulatory
requirements.
 Responsible for identifying duplicate/invalid ICSRs in ARIS and handling
as per relevant SOP.
 Responsible for generating and forwarding appropriate queries and requests
for clarification and/or follow up information
 Awarded four times as best performance award in the period of 1.5 years.
Demonstrated knowledge of safety concepts, global regulatory reporting
obligations, relevant PDSO SOPs, Pharmacovigilance Agreements and Safety Data
Exchange Agreements
WORK EXPERIENCE AS QUALITY CO-ORDINATOR in PFIZER PRODUCTION
PLANT
 Worked as Quality coordinator at PFIZER Ind LTD in Quality assurance and
MICRO department From Jun 2011 till Sep 2012.
 Performing dissolution, Analytical tests for all raw materials and finished products,
all types of chromatography.
 HPLC and GC for all products.
SKILLS
 Fluent in English and other local languages both verbal and written.
 Good interpersonal and communication skills.
 Good knowledge of ICH-GCP guidelines.

4. INDUSTRIAL TRAINING COPMPLETED
 Pathology Departmentat BSES Hospital, 2007
 In Plant Tissue Culture at Shreedhar Bhat’s Laboratory, 2008
 Genetic Engineering Workshop At Mitcon Bio-Pharma, 2009
 Pfizer India Limited, in Quality Assurance Department Microbiology, 2010 for 3 months
EDUCATIONAL DETAILS
Qualification
Year of
Passing
College Status
Master of Science in
Biotechnology
2011 VIVA College, Virar,
Mumbai University
65%
Bachelor of Science in
Biotechnology
2009
MVLU college of Arts Science and
commerce, Andheri, Mumbai
University
66%
H.S.C 2006 Maharashtra Board, Mumbai
university
71.17%
SSC 2004
Maharashtra Board, Mumbai
university
82.26%
PERSONAL PROFILE
Father’s Name : Girish Patel
DOB : 16.08.1988
Age : 27 Years
Blood group : O +ve
Gender : Female
Marital Status : Single
Languages : English, Hindi, Marathi and Gujarati
Nationality : Indian

5. REFERENCES
DR. S.G. Balachandra, Dr. M. Dinakaran,
Team Manager, Team Leader,
Cognizant, Cognizant,
Mob: +91-7045105219 Mob: +91-9167482820
DECLARATION
Place: Mumbai Yours Sincerely,
Date:
Priyanka Patel