Contact
www.linkedin.com/in/dr-razia-
sultana-b8b39521 (LinkedIn)
Top Skills
Testing
Requirements Analysis
SDLC
Languages
English, Hindi, Urdu, Bengali
Certifications
ARGUS
ARISg
Honors-Awards
o Bagged 5 Spot Awards ( for Job
well done) consecutively for 4 years
in Aris Global
o Performer of the month award
consecutively for four times in Aris
Global
o Winner of 2 Spot awards in
Novartis for contribution E2B
Project and training the Cognizant
associates on E2B report handling.
o Winner of Above and Beyond
award in Novartis for contribution to
Swissmedic E2B project.
o Winner of Above and Beyond
award in Novartis for SME support
during NCH Quality Audit.
 
dr. razia sultana
Associate Principal- Validation at Prudentia
West Godavari
Summary
I am a ‘roll up your sleeves’, act like an owner and just love what I do
kind of a person. A Risk taker, passionate about work, go-getter, and
solutions thinker…
 Techno- functional professional in Pharmacovigilance domain
having more than 7 years of experience in drug safety with
significant understanding of the functional and technical aspect of
drug safety software platforms
 Experience in Healthcare & Life Sciences industry spanning from
IT services, Pharmaceutical & CRO industries
  Experience with validation of ARGUS (Core and LAM), ARISg
and affiliated modules (e.g., IRT, OST, ESM, etc...)
 Knowledgeable on ICH and its working products, Electronic
standards, Reporting requirements, etc...
Member of the E2B Core team in Novartis.
 Participated in various Audits and Inspections in ARIS global, and
Novartis as an SME.
 Trained in running various line listings using applications like
ARISg, TOAD, CITRIX, AIR and ARGUS.
 Well versed with working on Sales data, PADERS and PSUR
processes, License partner LL's.
 Have been onsite for customer training and gathering Business
Requirements .
 Provided Extensive remote training to customers like JnJ, GE,
Endo, Santen, Array BioPharma, PPD, Merz, LundBeck, Cemed,
Bosch and Lomb , Roche, Biogen, Aspen, IPCA, LFB, Abbott, etc. on
various pharmacovigilance software.
 Created numerous case processing instruction documents for
various pharma companies.
 Have been leading teams in planning and designing of test
plans and strategies, test cases and test scripts/procedures, UAT
activity and gap analysis to ensure that business requirements and
functional specifications are tested and fulfilled.
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 Demonstrated excellence in steering consulting assignments like

interacting with clients, managing client challenges, providing client
solutions and managing large organizational changes.
 An effective leader with proven abilities in leading teams during the
project phase, training & guiding team members

Experience
Prudentia Group, LLC
Associate Principal- Validation
November 2018 - Present (2 years 3 months)
India

Novartis
5 years

Safety Systems Expert

May 2017 - Present (3 years 9 months)
Hyderabad Area, India

E2B Coordinator/ Pharmacovigilance Data manager

February 2016 - Present (5 years)

GSK Consumer Healthcare India

Pharmacovigilance Data Manager
October 2015 - January 2016 (4 months)

Novartis
Pharmacovigilance Data Manager
February 2014 - September 2015 (1 year 8 months)
 Part of the E2B core team in Novartis,
 Trained in applications like TOAD, CITRIX, AIR and ARGUS.
 Well versed with working on Sales data, PADERS and PSURS, License
partners, Late Breaking info, Product configuration, etc.
E2B coordinator for NCH ( Poland, Croatia, Canada, South Korea ,
Switzerland, Sweden, Ireland..)
• Responsible for preparing the configuration checklist and co-ordinate with
other sectors to have all details entered in one form.
• Identify testers for formal validation and schedule training sessions.
• Schedule test reports for connectivity testing and for testers to practice
• Ensure that testers perform test script validation

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• Send as many reports as possible to verify the final Acknowledgements

• Track all issues in an issue log and study negative acknowledgements
received
• Involve GDSS team for issues related to configuration or mapping
• Address the need of updating local SOP of the concerned affiliate or Central
site
• Coordinate with Global Head Case Processing if there is a specific
convention or MAP amendment .
• Prepare test cases according to HA requirements and involve case
processing teams.
• Once the validation is completed, review & compilation of validated script and
evidences
• Preparation of test deviation, if any
• Send the reviewed script (and deviation, if any) for Project Business Lead’s
and then for Pharma QA’s approval
• Create New users request forms & send it to the Configuration support
• Ensure all working instructions are completed
• Update and Review E2B Documentation
• Provide technical support to DSP business processes, including generation
of reports and first tier application support; participate in projects to implement
new technologies
• Generate data reports for Annual Periodic Reports and Product Reviews
• Participate in special projects to drive compliance and efficiency
improvements
• Participate in data migration; work with partner systems reps to coordinate
and resolve issues

Aris Global
5 years

Subject Matter Expert (SME)

January 2013 - January 2014 (1 year 1 month)
Bangalore

• Being responsible for authoring Functional Specifications of new

requirements along with customer issues and tickets
• Global Pharmacovigilance Business Process, EU PV regulations &
requirements. Excellent analytical skills and creativity in proposing multiple
options/solutions to a requirement, and select the best based on various
priorities like time for development, usability, maintainability, etc
• Experience in working with customers to understand customer requirement
and convert these into Requirements Documents.

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• Experience in product or project management, including preparation of

requirement documents, UI design and use case scenario’s
• Understanding of product life cycle management
• Experience with managing development projects, including documentation
review and testing activities
• Working with product owners/customers to understand product background &
requirements
• Analyzing requirements and generating use cases, activity diagrams along
with detailed functional specifications document or User Stories for assigned
functionality
• Working with User Experience team to develop and refine prototypes
• Working with developers to ensure they understand all aspects of the
requirements, including assisting with the logical data modeling
• Working with the QA team to ensure corresponding test cases are reviewed
before development is completed
• Work with the product owners & project managers to assist in Agile
development processes, such as verifying user stories’ status per iteration,
demos to product owners, etc.

Senior Application Support/ Business Analyst

December 2009 - January 2013 (3 years 2 months)
• Expertise in new regulations (EV 7.2, EMA New requirements, DSUR
etc) introduced in Drug Safety and Regulatory Reporting Domain and
corresponding process changes with respect to CSV.
• 21CFR Part11 and GxP guidelines, Good Pharmacovigilance Practice
(GPvP),
• MedDRA coding, WHO Drug Coding.
• PV Compliance & Quality Management.
• Knowledge on ICSR DTD, ICH E2B data elements
• Professional experience in Validation Practices with a good understanding
of GXP (GMP, GCP, GAMP 4.0) standards, FDA (21 CFR Part 11) and EMA
regulations.
• Experience in development of Validation Protocols like Installation
qualification (IQ), Operational qualification (OQ), and Performance qualification
(PQ) for the related applications.
• Expertise in reviewing and preparing Validation documents like requirement
Documents, Master Plans, Test Scripts and Test cases and all Validation
Deliverables.

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• Experience in writing Test plans, Test cases, Test Scripts, Test Procedures
and coordinating UAT (User Accepting Testing) within quality Center
application.
• Experience in reviewing and modifying URS (User requirement
Specification), FRS (functional Requirement specification) and TAD (Technical
Assessment Document)
• Good Knowledge in reviewing current operating procedure and develop new
Standard Operating Procedures (SOPs)
• Also experienced in preparation of Risk analysis matrix and Traceability
matrix, based on requirement understanding and Application functionality
expertise.
• Responsible for account level trainings of all the teams on, validation,
Pharma expectations, new regulations (like EV 7.2, DSUR, EMA regulations-
Changes in Reporting Periods in Volume 9), 21 CRF part 11, GAMP 5.0 etc

SME
2009 - 2013 (4 years)

Ashirwad Dental Clinic

Dentist
October 2007 - November 2009 (2 years 2 months)
• Practised as a dental surgeon.
• Performed dental services like scaling, bleaching, dentures, extractions, root
canal treatment, fillings, crowns and bridges, etc...

Education
Oxford Dental College
B.D.S, Dentistry

D.B.M.S English School

10+ 2, PCMB

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