Contact
8105068071 (Mobile)
nishal.abhinav@gmail.com
www.linkedin.com/in/abhinav-
gaddam-1257481b (LinkedIn)
Top Skills
Biotechnology
Management
Screening
Languages
English (Native or Bilingual)
Hindi (Full Professional)
Telugu (Native or Bilingual)
Certifications
Certificate of Proficiency for
Japanese (N5 Equivalent)
Good Clinical Practices
Pharmacovigilance and drug safety
 
Abhinav Gaddam
Literature Reviewer/Medical Safety Activities at Cognizant
Hyderabad, Telangana, India
Summary
Trained and certified in Pharmacovigilance and drug safety adverse
event reporting and assessment, signaling and risk assessment.
Acquired 7 CPD points from the Faculty of Pharmaceutical medicine
of the Royal college of Physicians of United Kingdom. Looking
forward for a challenging position in drug safety department of
Pharmacovigilance.
My skills in Pharmacovigilance include:
. Adverse event (AE) reporting.
. Expedited reporting requirements.
. Reporting requirements in special situations (Submission and Grant
of MA).
. PSUR reporting requirements.
. Benefit risk assessment and improving the benefit- risk balance.
Also Familiar with:
. Role of various parties in EU Pharmacovigilance system.
. Roles and responsibilities of marketing authorisation holders(MAH).
Experience
Cognizant
3 years 2 months
Document Reviewer - medical safety signal expert
August 2016 - Present 
Hyderabad Area, India
• Provide safety to the Brand Safety Leader/ Pharmacovigilance Leader
(PVL/BSL) in monitoring the safety profile of assigned products by screening
literature reports to identify those that include safety information for further
review.
• Assist the BSL/PVL in literature review of high volume products by identifying
literature reports which needs further medical evaluation.
• Enter comments of BSL/PVL (e) into LiSA system.
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• With BSL/PVL (e)s, modify criteria for identification of reports requiring

medical review as required.
• Train other CTS colleagues as required.

DATA ANALYST
July 2016 - August 2016 (2 months)
Hyderabad, Telangana, India

• Processed Clinical Trial, Spontaneous Individual Case Safety Reports

(ICSRs) based on time line prioritization.
• Review and process adverse events reported by investigators.
• I have an overall End to End process experience in Case Processing, Triage
and Quality review of ICSRs in both Post Marketing and Clinical Trial space.
• Processing of Clinical trial, Spontaneous, Literature, Business Partner,
Health Authority, E2B cases across therapeutic areas majorly Oncology and
Neurology products.
• Coding of drugs using CDD and WHO drug dictionaries accordingly.
• Raising query and Follow up letters for further information about the report in
the time of requirement.
• Writing concise, accurate case narratives for serious and non-serious cases
as per client conventions.
• Effectively maintains the safety database and corresponding entry guidelines,
including accurate entry of data and assurance of quality of data through
quality control process.
• Performing consistent coding of adverse events, medical history and
medications according to the project specific coding conventions using
MedDRA.

Quintiles
Operation specialist associate
June 2015 - June 2016 (1 year 1 month)
•Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event
to ensure accurate and consistent data entry and processing from source
documents, with emphasis on timelines and quality. Ensure accurate and
consistent coding of medical history, drugs and adverse event terms.
• Assess adverse event reports for seriousness, causality and expectedness
as per the Investigator Brochure/Basic Prescribing Information/US package
insert, consulting the Medical Safety Expert whenever needed. Determine the
necessity for follow-up and prepare follow-up request as needed.
• Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists
from other processing sites and Medical Safety Physicians (Pharmacovigilance

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Leader and Brand Safety Leader) to ensure that reports are accurately
evaluated and databased.
• Triage literature cases for databasing or pass them on to the Team Leader
for approval of rejection. Co-author, together with the Medical Safety
Physicians, all required regulatory periodic re-ports, collecting, organizing
and presenting the available data. Work with external partner groups, e.g.
co-licensing partners and Clinical Research Organizations to meet joint
accountabilities
• Assist the Medical Safety Physicians with project activities in specific
therapeutic areas, compatibly with the timely processing/production of
individual case reports and regulatory periodic reports. Be involved in
development and testing of safety systems/IT applications and in the
preparation of relevant manuals. Participate in cross-functional teams on
safety matters/DS&E special projects relating to investigational and marketed
drugs Impact on the organization. Ensure that Serious Adverse Event /
Post Marketing Adverse Event are evaluated accurately and within the
required timeframes to meet regulatory requirements. Alert the Medical Safety
Physicians to potential safety issues
Trained in EMPIRICA TRACE with the essential functionality in coding, E2B
languages.

iMEDGlobal Corporation
Drug Safety Associate
March 2014 - June 2015 (1 year 4 months)
Bangalore

• Review all case reports for case validity and perform case processing to
ensure all the data are captured appropriately.
• Review all case reports for errors, missing information, legibility by
performing quality check of case against the source document and entering
any data found relevant during the assessment.
• Encode verbatim terms using MedDRA for medical history, product
indication and adverse events.
• Responsible for writing narrative summaries by checking all data has been
provided according to the related SOP on reported adverse event cases.
• Review, enter and verify follow-up information from spontaneous sources and
clinical investigations.
• Ensure the timely submission of reports to worldwide regulatory agencies in
accordance with applicable regulations.
• Responsible for providing assistance to all the team members when required
with respect to case completion.

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• Perform daily responsibilities in accordance to all applicable Standard

Operating Procedures (SOPs), conventions and client policies.
• Plan, organize, and manage daily work to meet service level timelines and
deliverables.
• Work with the team lead to escalate issues or tasks outside the normal scope
of work.

Totley pharmaceutical industry

Drug Safety Associate
January 2013 - January 2014 (1 year 1 month)
Totley dore

Responsible for the collection, detection, assessment, monitoring and the

prevention AE reporting.
Assisted with individual case reporting and successfully dealt with assessment
and reporting.
Successfully able to master audit trials for Individual case reports through
ARISg software.
Was successfully able to submit IFR reports to FDA for the Suspected
products.
Genereating reporting timelines for submission to regulatory authorities

Dr. Reddy's Laboratories

Drug safety associate
April 2012 - October 2012 (7 months)
1.Responsible for receipt and data entry of adverse event reports following
company Standard Operating Procedures, internal business practices
and regulatory guidance documents to ensure compliance with
worldwide safety regulations and corporate policies.
2. Favourable with the expedited reporting of adverse event to the regulatory
authorities, third parties.
3. Analysing the ICSR reports and sorting them according to the SAE criteria.
4. Follow up information with the minimum criteria was actively sorted and
submitted.

Tini Pharma
Production Operative techinician
November 2011 - September 2012 (11 months)
1. Worked in tablet production unit in aseptic areas.
2. Sampling of powders during blending, production, packaging and record for
QC.

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3. Complying with Indian Pharmacopoeia in-house test during production like

weight variation, disintegration.

Sheffield Hallam University

Graduate
August 2010 - October 2011 (1 year 3 months)
Pursued course containing core modules like molecular biotechnology ,
molecular pharmacology and new drug development.

Education
The English and Foreign Languages University, Hyderabad
High School Diploma, Japanese Language and Literature · (2019 - 2020)

Rama krishna math

Certificate of proficiency, Japanese Language and Literature · (2018 - 2019)

Sheffield Hallam University

Master's degree, Biotechnology · (2010 - 2011)

Sheffield Hallam University

Master's degree, Pharmacology · (2010 - 2011)

HRD Degree and PG college

Bachelor's Degree, Biotechnology and Biochemistry · (2006 - 2009)

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