drug safety associate, drug safety specialist, medical coder

DR.NAVEEN KUMAR SUJATHA

Email: aczan1@r.postjobfree.com Phone: 919-***-****

Career Objective:

Seeking an opportunity to work with a view to utilize my interest, credentials and work experience in the field of pharmacovigilance towards professional growth and development

Professional Strengths:

8 years of experience with Drug Safety/Pharmacovigilance in the pharmaceutical industry

Evaluating, Processing and Reviewing AE/SAE reports from various sources in compliance with the regulations without compromising the quality of work

Demonstrated competence in Triaging (Completeness, Legibility, and validity) to determine seriousness, Expectedness & Priority, Case processing’s that include duplicate searches

Experience in processing Individual Case Safety Reports (ICSR) for serious adverse events (SAE) and non-serious AE reports for post marketing and clinical studies

Extensive experience in data entry case processing, case merges inactivation, quality review and follow-up in accordance with US- FDA, ICH guidelines

Working Knowledge on Good Documentation Principles

Excellent command on medical terminology and expertise in the utilization of MedDRA for capturing coding patient medical history and coding SAE's and AE's ; products with company product dictionaries and WHO-DD

Experience in performing SAE reconciliation between safety database and clinical databases.

Extensive experience in draft preparation of PBRER’S/ PADERS and assisted in compilation different sections of safety report files

Managed the quality review of assigned documents

Maintained source documents for QC and edited them as per the safety updates

Assists in the preparation of SOP, Clinical trial protocol, NDA and IND safety reports

Ensured effective planning and management of timelines to meet worldwide regulatory requirements

Independently established work priorities & directions with minimal input from manager

Technical skills:

Safety database: Adverse Event Reporting System (AERS), Oracle Argus and Adverse Reaction Information System Global (ARISg)

Coding tool: Oracle's Thesaurus Management System (TMS) and Aris Global’s agEncoder

MS Office (Word, Excel, PowerPoint, Outlook)

Education:

Master’s Program in Business Administration (MBA), National Institute of Management (Bangalore), Specialization: Clinical research

Postgraduate Program in Pharmacovigilance, Cliniminds (New Delhi)

2 year (full time) Postgraduate Diploma in Clinical research, Institute of Clinical Research (India), (Bangalore)

Bachelor of Dental Surgery, Bapuji Dental College & Hospital (Davanagere)

Work Experience:

Biogen May 2014 to till date Medical coder

Perform medical coding (WHO Drug Dictionary Enhanced and MedDRA) activities maintaining optimal communication with SABR staff and SABR vendors for all post marketing cases managed by SABR as per Biogen Idec and/or applicable coding conventions

Perform medical coding activities for all in-house clinical trials maintaining optimal communication with internal DM staff and oversight of vendors performing coding for out-sourced (full service and FSP) clinical trials while maintaining optimal communication with vendor staff as per Biogen Idec and/or applicable coding conventions

Perform quality control and quality assurance activities for all medical coding activities, including in-house and outsourced coding activities

Coding tool: Oracle's Thesaurus Management System (TMS) and Aris Global’s agEncoder

Global Pharmatek LLC January 2014 to April 2014

Medical coder

Perform medical coding activities as per client specific Coding guidelines

Medical & Quality review of coding

Generated queries for clarification of data

Coding tool: Oracle's Thesaurus Management System (TMS)

Ecron Acunova Limited (Client TEVA Pharmaceuticals) September 2010 to September 2012

Lead Medical Coder, September 2011 to September 2012

Medical Coder, September 2010 to September 2011

Medical coding of adverse events using MedDRA and medications using WHODD-ATC

Medical & Quality review of coding

Reconciles adverse event, follow up and ensures case closure

Generated queries for collection of additional information for spontaneous adverse events.

Communicate with investigator, site for additional adverse event information

Assist in the preparation of SOP, Clinical trial protocol, NDA and IND safety reports

Assist in draft preparation of PBRER’S/ PADERS

Management of coding team & client interaction

As a senior experienced member of the medical affairs & pharmacovigilance department I was also responsible for supporting the following activities

Narrative writing for serious adverse adverse events occurring in clinical trials

Narrative review or compliance as per guidelines and internationally accepted standards

Coding tool: Oracle's Thesaurus Management System (TMS)

LUPIN Limited March 2010 to June 2010 Executive Drug Safety Associate

Perform Triage, data entry of spontaneous, literature, legacy, regulatory and clinical trial cases

Evaluate cases for seriousness, relatedness and expectedness

Reviews clinical study adverse events for accuracy, integrity and consistency according to project-specific guidelines

Coding events, diseases, indications and lab test using MedDRA

Safety narrative writing and quality review of all SAEs for data completeness

Reconciles adverse event, follow up and ensures case closure

Preparing PBRER’S/ PADERS drafts

Carrying out weekly, monthly, annually & cumulative literature searches

TATA Consultancy Services (Client Roche Pharmaceuticals) January 2009 to March 2010

Senior Process Associate/Drug Safety Associate

Reason for project change: Earlier project completed in October 2009

Performed tasks with quality & efficiency to meet company details for expedited & non-expedited reports

Received, performed data entry of the unstructured case data from the source documents and assessed adverse event reports from post-marketing, both serious and non-serious in safety database within global and local timelines

Identify duplicate cases, enter basic data into database, create tracking number and acknowledge receipt of case to sender

Determine whether case should be inactivated (whole case is invalid) or if follow-up report should be deleted because it is invalid

Evaluate cases for seriousness, relatedness, and expectedness

Performing accurate electronic and manual data entry coding into Argus database using the MedDRA and WHO-DD coding dictionaries

Review medical sense of report, check labelling assessment and scientific assessment

Safety narrative writing and quality review of all SAEs for data completeness

Adheres to required timelines for reporting to regulatory authorities, investigators and ethics committees

Ensure reports are compliant with ICH guidelines, FDA requirements, and internal SOP’s

Demonstrate the ability of handling ambiguity of source material by identifying medical and regulatory reporting inconsistencies

Safety database: Oracle Argus

FOR MLCH PROJECT: (Client AstraZeneca Pharmaceuticals)

Brief profile: It was a first legal project in India in pharmaceutical industry

Reviewing Patient’s Medical records, source data. Capturing serious and Non-serious adverse events, concomitant medications, concurrent diseases and medical history of the patient

Evaluate cases for seriousness, relatedness and expectedness

Performing accurate electronic and manual data entry, coding using the MedDRA and WHO-DD coding dictionaries

Safety narrative writing and quality review of all SAEs for data completeness

Forwarding the case for GDSP review and regulatory (FDA) submission. Complying with SOPs and ICH-GCP

Participate in client interactions and relevant teleconferences if required. Strategy planning for achieving the targets

Compliance: Worked with accuracy of 99.00%, Promoted as Internal Quality person

IRL Research Centre September 2007 to January 2009

Clinical Relation Executive

Patient recruitment and Maintaining database of patients

Preparing recruitment material like Dear Doctor letter, Dear Patient letter, Mail shots, Newspaper advertisements etc for Ethics committee approval

Organizing Health camps in association with GPs and Social workers etc. Carrying out feasibility for different studies

Networking and maintaining cohort with Gps, OPD doctors and social workers

Segregating patient’s database depending upon the studies. Telephone follow up to patients

Maintaining pre-screen and screen log of patients

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