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Data Entry Safety

Houston, Texas, United States
October 04, 2016

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Harsimrat Kaur

**** *** **** ****, *******, TX **063


Job Objective

To obtain a position in a clinical research setting with emphasis in drug safety and pharmacovigilance where my medical background and experience can be higly valuable. Career Summary

Feb 2012 – July 2015 Pharmacovigilance Specialist, Parexel International Services India Private Limited

(Former Quantum Solutions India).

Jul 2011 Feb 2012 Worked as a full time dentist in a private dental setup Education

Year 2006 2011 Bachelors in dental surgery (B.D.S) from National dental college and hospital, Derabassi

(Pb) India.

Summary Skills

Proficiency in initiation and data entry in drug safety database

Remarkable knowledge to monitor and track Serious Adverse Events

Indepth knowledge of US and ICH safety reporting regulations and guidelines

Capability to make concise, accurate ant relevent synopses of medical text and data and abilty to write unambiguous medical text

Good knowledge of medical terminology

Experienced in identifying/formatting/responding to queries

Ability to evaluate and draw conclusions independently

Fluency in written and spoken english

Computer proficiency to work with web based applications and the MS Office suite

(Word/Excel/Powerpoint) and in handling the ERP systems (Enterprise Resource Planning)

Good experience in providing mentorship to team colleagues Professional Knowledge/Work Experience:

Pharmacovigilance experience as PV Scientist

Experienced in management of Individual Case Safety Reports (ICSRs) of all case types

(spontaneous, clinical studies, solicited programmes, serious or non serious and Licensee cases) which includes:

triage of ICSRs to determine whether they qualify for expedited reporting (determine the validity of a report) or not and the timelines within which they need to be submitted to the regulatory authorities

Experienced in

Registration/initiation of ICSRs into the safety database

Conducting duplicate searches prior to registration and identifying potential duplicates

Managing duplicate cases appropriately

Trained in

Coding of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required

Conducting inactivation and deletion of invalid ICSR processing of ICSR's

Data validation i.e. cross checking against source documentation

Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”

Working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including

ICH guidelines on safety and efficacy

Volume 9A

FDA guidelines


Trained in

Global Compliance Monitoring of ICSR’s

Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting

Served as a Late case reviewer

Assesment and capturing of lateness reasons of the ICSR's associated with the products on worlwide basis on the drug safety database, in accordance with International and local regulatory requirements

Served as a PV Analyst ( formerly titled "Global Compliance Analyst")

Ensuring Compliance of ICSR with company and regulatory requirements

Implementing and maintaining systems, processes, and metrics to monitor quality, performance and compliance of safety activities and deliverables in the key areas of compliance, quality and performance.

Assisting and ensuring corrective and preventative action plans are in place in response to audit or inspection findings, or in response to internally identified trends in errors or other non compliance, in coordination with other Compliance teams and stakeholders.

Sending monthly communications to license partners (LP) and affiliates and collecting lateness and Corrective and Preventive actions (CAPA) for late EMA and FDA submissions

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