Safety Medical

Flat No: FA, Trinity Men's Hostel

Plot No: ****, Ayappa Society

Madhapur, Hyderabad -

*** ***

India

Email: **.************@*****.***

Tel: +91-995**-*****

Dr. R. Arun Kumar, BDS, PDCR, MCIP

WORK EXPERIENCE

Novartis Healthcare Private Limited, India

Apr 2009 - Present

Safety Processing Expert

Serious adverse event reporting

. Receive information on adverse events, perform initial checks, search

database to prevent duplicate entries, create case file and initialize

received drug safety reports in the DS&E tracking tool and/or safety

database.

. Ensure scientific rigor through accurate, complete and consistent data

entry of adverse event reports from source documents with emphasis on

timeliness and quality.

. Evaluate and finish processing of non-expeditable AE reports, including

review for completeness and accuracy.

. Coding of drugs by Novartis drug dictionary and WHO drug dictionary.

. Coding of adverse event terms and medical history, accurately using

MedDRA.

. Assessment of case reports for seriousness, causality and expectedness.

. Prepare narratives by summarizing the essential details of the case.

. Identify clinically relevant information missing from case report and

facilitate its collection (in consultation with medical staff as

required) by preparing follow-up request as needed.

. Work with Novartis country safety departments, Clinical Safety Scientists

and Pharmacovigilance Leaders, License partners to ensure that reports

are accurately collected, evaluated and databased.

Periodic safety reports

. Author/Co-author with Pharmacovigilance Leader for preparing Periodic

Safety Update Reports (PSUR), Addendum Report (AR) and Summary Bridging

Report.

. Collecting, organizing, analyzing and presenting the available data in

Novartis templates and in accordance with Volume 9A requirements.

. Releasing the final document to Health Authorities (HA) within the

specified timelines.

. Providing QC of periodic reports.

Signal detection and RMP activities

. Reviewing line listings and summary tabulations, periodically.

. Alerting the manager for potential safety signals based on incoming case

reports.

. Assisting in the Risk Management Plan (RMP) implementation by close

monitoring of the safety findings in previous PSUR and other newly

identified relevant safety findings.

Literature review

. Screening of literatures in LISA (Literature Search Application).

. Escalating the valid article qualifying for safety databasing.

. Ordering the full text article, if an abstract seems to be a valid case

for databasing.

Database validation

. E2B reports from HA - Implementation and validation of Argus database for

incoming E2B reports from Health Authorities of Denmark and Norway at the

initial test run in Novartis Pharma.

Argus and SINA reconciliation

. Mapping of data between Argus and SINA.

. Resolving the discrepancies by updating and modifying the data based on

the source documents.

. Resolving the discrepancies by updating and modifying the data, based on

the source documents.

. Support DS&E projects or database validation activities, as required.

Root cause analysis with Corrective And Preventive Action (CAPA)

. Identifying the exact root cause for late cases expedited to regulatory

authorities.

. Providing the corrective actions and suggestions to prevent any cases

being late and for achieving a good compliance rate.

Quality Control (QC) and Audits

. QCing of Individual Case Safety Reports (ICSR) processed by other members

in the team.

. QC by in-house QC tool for cases in Argus database, periodically to

correct errors which are deviated from Novartis data entry conventions.

. Preparing and maintaining the documents in accordance with Novartis SOP's

and Health Authority requirements as well as by assisting the therapeutic

area members at the time of Health authority inspections and audit

trails.

Mentorship

. Providing training to the new joiners as well as interns and assisting

them in the production environment based on the business needs and in

specified time lines.

LEAN

. Supporting the implementation of LEAN activities in DS&E, India.

. Assisted in a smooth transition of therapeutic area into LEAN process

leading to a highly effective production environment in terms of quality

and compliance rates.

Databases

. ARGUS Safety TM Version 4.2

. SINA (Safety Information Notification Application)

. LISA (Literature Search Application).

Management skills - Therapeutic Area Coordinator

. Managed a team of seven SPE's in Immunology and Infectious Disease (IID)

Therapeutic Area (TA).

. Responsible for incoming cases in IID TA and ensuring them to be

processed within internal time lines.

. Allotting cases to the processors in rotation as well by taking into the

account of individual skills and responsibilities.

. Attending the workload management meeting, daily to decide about the

total inflow of cases in the floor and exchange of cases and resources

between different therapeutic areas by taking into consideration of the

time critical cases and available resources.

. Leave management within TA.

. Conducting monthly meeting in TA to identify needs and concerns, for an

individual or as a group.

. Submitting monthly reports to Group Heads about different activities

within TA.

. Assist with related administrative and procedural activities as required

or requested.

ICON Clinical Research Private Limited, India Jan

2008 - Mar 2009

Drug Safety Associate

Serious adverse event reporting

. Triage of incoming cases to determine seriousness for prioritization of

daily workflow.

. Checking for any duplicates and completion of data entry in the ARISg

safety database.

. Querying to the investigational sites and reporters on safety related

issues or for any clarifications in the cases.

. Following-up of cases with events of special interest.

. Complete quality reviewing of our own or cases of other members.

. Processing reports within ICON, regulatory authorities and sponsor

regulations and timeframes.

. Interdepartmental liaison between medical staff and other ICON

departments for safety related issues.

. Liaison with Sponsors, Clinical trial sites as well as external vendors

for safety and project related issues.

Narrative writing

. Preparing comprehensive narratives procured from relevant, related

information from various source documents.

. Preparing safety summaries for clinical studies.

. Writing narrative in our own way or by auto-narrative in a simplified and

concise manner.

. Updating the narratives in follow up cases.

Case Report Form (CRF) review

. Reviewing CRF's and contacting the sites for any clarifications in the

CRF.

. Medical reviewing of data listings and SAE reports.

. Identifying hidden SAE/AEs.

. Raising queries for any deviations and violations based upon the protocol

to the investigational sites and Clinical Data Management team.

. Resolving discrepancies related to safety data.

Lab review

. Complete review of the laboratory values and capturing values which are

deviated or violated from the protocol.

. Raising and resolving discrepancies related to safety data.

SAE reconciliation

. Verifying that all SAEs captured in the clinical trial database are

captured in the Safety database.

. Obtain report listings of SAEs from the Safety Database for

reconciliation.

. Resolving all discrepancies between the SAEs that are present in clinical

trial database and Safety database.

. Contacting Clinical study team and sites depending on the nature of the

discrepancies.

. Preparation of SAE Data reconciliation forms.

. Updating the Safety Database depending on the resolution outcome.

. Local QC reviewing in the Safety Database.

Lab graph drawing

. Analyzing laboratory values and plotting graphs in spread sheets as per

the client's need.

. Interpreting lab data on the graphs depending upon the marked variations

in values for study subjects and report generations.

Literature search

. Literature searches to identify adverse events for inclusion in the

global safety database.

Feasibility study

. Web searches of trials around worldwide as per criteria's given by the

clients and populating them in spread sheets to serve as a guide for

client's future trials.

MedDRA and WHO-DD coding

. Coding of adverse events and medical history terms using MedDRA.

. Coding of medications using sponsor drug dictionary and WHO Drug

Dictionary (WHO-DD).

. Reviewing of auto-coded terms.

. Liaise with data manager to raise and resolve discrepancies associated

with coding.

Databases

. Adverse Reaction Information System-global (ARISgTM ) version 3.0, 5.0

and 6.1

. Optimised Paperless Tracking and Information Control (OPTICON) version

2.0

. Oracle clinical

. RAVE version 5.4.1

Management skills

. As a Coordinator for a team of about 5 Drug Safety Associates -Entry

Level (EL)

. Distribution of tasks to the team mates on rotational basis.

. To mentor a new Drug Safety Associate-EL and assist with their training.

. Escalating issues faced by team mates to higher management.

. Conducting weekly project specific team meetings.

. Planning of team mate's leaves and attendance maintaining.

. Maintain metrics/staffing reports of team mates.

. Assisting resource allocations depending upon the needs for projects.

Medusind Solutions, India

Apr 2007 - Dec 2007

Medical Analyst

. Coding by United Nations Standard Products and Services Code (UNSPSC).

. Market research analysis of Medical devices and drugs based on the

client's needs.

. Internal QC review

Internship (Dentistry)

Mar 2006 - Mar 2007

Underwent one year Compulsory Rotatory Residential Internship (CRRI) in

Tamil Nadu Government Dental College & Hospitals, India. Trained in Oral

Medicine and Radiology, Oral and Maxillofacial Surgery, Orthodontics,

Operative dentistry, Endodontics, Periodontics, Pedodontics, Preventive

and Community dentistry, Prosthodontics, Oral pathology, Pharmacology,

Histology, Microbiology, General surgery and General Medicine.

TRAININGS

. Successful completion of ICON Safety Boot camp.

. Completed ICON Safety college training.

. ICH-GCP training conducted by ICON Clinical Research.

PRESENTATIONS

. Clinical trial designs and Adaptive trials

. European Society of Hypertension guidelines (ESH, 2003)

AWARDS & RECOGNITIONS

. "Above and Beyond Award" towards writing the best Periodic Safety

Update Report/ Addendum Report (07 Jun 2010, Novartis)

. "Above and Beyond Award" for the Argus workflow change OQ script

writing (08 Jul 2010, Novartis)

STRONG ATTRIBUTES

. Ready to imbibe new concepts and learning new things

. Concern for productivity with good quality and quantity

. Good attention to detail and accuracy

. Flexibility/Adaptability to workload and timelines

. Good team player by establishing and maintain effective working

relationships with coworkers, managers and clients

. Excellent problem solving skills.

. Ability to work independently and to collaborate

. Good written and verbal communication skills

. Positive attitude

EDUCATION

Bachelor of Dental Surgery (B.D.S), Tamil Nadu Government Dental College

& Hospitals, Chennai-3 under Tamil Nadu Dr.M.G.R Medical University,

Chennai-32 (Oct 2001 - Feb 2006) Marks: 64% (First Class)

PDCR (Professional Diploma in Clinical Research) in Catalyst clinical

research, Delhi

H.S.C, S.R.V Higher Secondary School, Rasipuram, 2001 Marks: 93.8%

(Distinction)

S.S.L.C, Cheran Matriculation Hr Secondary School, Karur, 1999 Marks:

88.0% (Distinction)

Continuing Education -- Master's program in Business Administration

(MBA), The Indian Institute of Business Management & Studies (IIBMS),

Mumbai, by distance mode, 2009 to till now.

PROFESSIONAL MEMBERSHIPS

. Registered Dentist in Tamil Nadu Dental Council, India (Registration

Number: 9907)

. Indian Dental Association

. Member of Council of Independent Practitioners (MCIP), Chennai Branch,

India

SKILLS

. Computer literate in Microsoft Word, Microsoft Office, Microsoft Power

point, Microsoft Excel, Microsoft Access, Microsoft Paint, Microsoft

Outlook, Internet browsers and Windows 95/98/2000/XP/Vista/Seven

operating systems.

. Conducted three school dental health camps in Government primary schools,

Chennai, India.

. Fluency in English and Tamil.

PERSONAL DETAILS

Date of Birth : 14 Jun 1984

Sex : Male

Nationality : Indian

Marital status : Single

Passport number : G6481546

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