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Abhinav Resume
Abhinav Resume
Contact
8105068071 (Mobile)
Abhinav Gaddam
[email protected] Literature Reviewer/Medical Safety Activities at Cognizant
Hyderabad, Telangana, India
www.linkedin.com/in/abhinav-
gaddam-1257481b (LinkedIn)
Summary
Top Skills Trained and certified in Pharmacovigilance and drug safety adverse
Biotechnology event reporting and assessment, signaling and risk assessment.
Management Acquired 7 CPD points from the Faculty of Pharmaceutical medicine
Screening of the Royal college of Physicians of United Kingdom. Looking
forward for a challenging position in drug safety department of
Languages Pharmacovigilance.
English (Native or Bilingual)
Hindi (Full Professional) My skills in Pharmacovigilance include:
Telugu (Native or Bilingual) . Adverse event (AE) reporting.
. Expedited reporting requirements.
Certifications . Reporting requirements in special situations (Submission and Grant
Certificate of Proficiency for of MA).
Japanese (N5 Equivalent)
. PSUR reporting requirements.
Good Clinical Practices
. Benefit risk assessment and improving the benefit- risk balance.
Pharmacovigilance and drug safety
Experience
Cognizant
3 years 2 months
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DATA ANALYST
July 2016 - August 2016 (2 months)
Hyderabad, Telangana, India
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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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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Education
The English and Foreign Languages University, Hyderabad
High School Diploma, Japanese Language and Literature · (2019 - 2020)
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