[var] => content
[type] => preview
[var] => cut_url
B, Shanti apartments,
No: /, Balakrishna road,
Chennai – .
Tamil nadu. Email:
pursue a challenging career in clinical research especially in Pharmacovigilance
Drug Safety and in clinical monitoring where I can put all my knowledge
acquire skills and contribute to the growth of my career, my team and
effectively to the organization.
dynamic, disciplined, confident, and goal oriented.
professional with excellent clinical, communication, interpersonal and
problem solving skills
and problem solving skills with clinical knowledge to consistently deliver
improved research and production results.
Good Team player
dedicated to quality, continuous improvement and bottomline objectives.
Good knowledge in
ICH GCP and Medical Terminologies.
Able to work independently
in safety related duties manage and mentor other employees.
and team building skills.
EXPERIENCE – yrs and months
– Pharmacovigilance in HCL Technologies Ltd – From Aug
to till date.
Practitioner from Nov to till date.
Safety Associate in MMSH clinical research Pvt.Ltd – From Jan
to Jul .
Drug Safety Associate
in Icon clinical research – From Jan to Dec
as Pharmacovigilance Consultant in HCL Technologies Ltd,
Worked as Senior
Drug Safety associate in MMSH clinical research, Bangalore,
Worked as a Drug
Safety Associate in Pharmacovigilance at ICON Clinical Research,
Chennai, Tamilnadu, India.
Worked as a Lead
DSA for the projects involved and directly reporting to project
manager and mentoring the reporting DSA’s.
More than three
years of clinical experience and Pharmacovigilance experience.
Assisted in setting
up a Pharmacovigilance department and PV call center Adverse
event reporting center in MMSH clinical research Pvt, Ltd. India.
HCL Technologies LTD:
HCL Technologies is a global IT services company
headquartered in Noida, a suburb of Delhi India. It is a billion$ enterprise.
The life science vertical of HCL service offerings in pharmaceutical
area includes Clinical trail management, Clinical data management, Pharmacovigilance,
Medical writing and Analytical services.
MMSH Clinical research:
The company is an ISO :
Certified organization located in Canton, Michigan. They provide clinical
development support, medical writing, clinical programming, biostatistics,
Pharmacovigilance services and regulatory affairs services to the pharmaceutical,
biotechnology and medical device industry.
Icon clinical research:
The Company is the global provider of
outsourced development services to the pharmaceutical, biotechnology
and medical device industries. Specialized in the strategic development,
management and analysis of programs that support Clinical Development,
i.e., from compound selection to Phase IIV clinical studies.
In that medical and safety services includes Medical affairs, Drug safety,
Medical writing, Phase IV studies and registries many other full service
Clinical Research Skill:
narrative writing and Reporting Paper format and Safety databases
and Safety Data analysis in live clinical trials.
Post marketing Safety
Review and Safety Data Analysis. Using safety database
Case Report form
Safety Review and query generation. Clinical Database
Review & data analysis, data interpretation in graphs and tables.
& Feasibility surveys.
and FTE preparation.
Preparing SOPs and
Study Master File
maintenance & Project audit preparation.
Training and mentoring DSA’s
Assisting in setting up of
Pharmacovigilance practice and dept in HCL technologies Ltd.
Conducting internal Pharmacovigilance
trainings and workshops.
Attending Business calls
with clients in order to get project and responding to RFP’s.
Supervision of other Drug
Safety Associates and Administrative staff in conjunction with the Medical
Ensure all project
safety activities are completed in accordance with SOPs, SSPs, and other
Maintain and review
department status reports, keep upper management apprised of any potential/actual
study or staffing issues, and assist with developing solutions.
Supervise project audit
preparation and project audit process Maintain metric/staffing reports
with thin the team.
between medical staff and other departments for project related issues.
at all Quality Review meetings pertaining to medical projects with in
Supervise File Room
activities and maintenance of File Room Maintain study activity checklists
to define scope of work for each project with the help of medical monitor.
Liaison between medical
staff MM, DSA, and Management for project related issues as required.
Preparation of presentations
and other relevant records for training the candidates in Pharmacovigilance
Preparation of work
flow, templates and forms needed for the PV department.
Assist with department
training and identify training needs as necessary.
Mentoring Drug safety
associate – ELs and DSAs in Pharmacovigilance duties.
Preparation of metrics
for the projects and the team.
. Receive, track, and assess AE and SAE reports from all sources including
postmarketing, clinical trial, and literature sources.
Document and process serious adverse event reports within company, regulatory
authorities and sponsor regulations and timeframes and enter data into
adverse event database / tracking system and paper files.
Argus, Oracle AERS, OC RDC, Oracle clinical and ARIS exchange
IRT working experience.
. Perform administrative tasks relevant to the role to include maintenance
of tracking systems, paper files and any other administrative tasks
. Liaise with investigational sites and sponsors on safety related
. Assist medical monitor in review and followup of laboratory abnormalities
and perform safety review of clinical data. Create graphs and tables
for the reported lab data.
. Perform tasks resulting from departmental interfaces, e. g. with
data management listing review, SAE reconciliation, medical writing
narrative review and writing.
. Review study documents and setup study specific processes together
with the assigned medical monitor and generate the corresponding procedures.
. Worked in literature review
projects and feasibility studies.
Reviewing literature article, identifying adverse drug reactions ADRs
raising CIOMS forms and narrative when required.
. Experienced in CRF safety
review related works and finding hidden SAE/AE and other queries to
site as well as to data management.
. Good working OPTICON
medical review Oracle clinical and RAVE medidata.
. ICH GCP trained
and trained in MEDRA Coding.
. Good knowledge in preparing
metrics and FTE calculations in MS excel.
. Preparing and maintaining
Study Master File and preparing CDDF and maintaining all study related
SAE Processing and Reporting:
This project was done for one of the big pharmaceutical company from
Japan, providing medical monitoring support globally for the product
used for Type Diabetes in their clinical trial. The main duties from
the Pharmacovigilance/drug safety team is to find out the adverse events
from the case report forms, raise missing queries, coordinating with
hospitals/clinical trial sites in order to get the relevant information
for processing the case and send the package to the sponsor.
Therapeutic area: Type
SAE processing and
Contacting the trial
site for relevant information.
Case report form
safety review using OptICON and find AEs.
monitor in medical safety review.
Role: Drug Safety Associate
This Project was done for the top pharmaceutical company from France
with their major therapeutic areas like Cardiovascular, Oncology &
Thrombosis providing clinical trail, medical monitoring and Drug safety
support in clinical Trails. The main duties from the Pharmacovigilance
team is to Check any Serious adverse events has been reported, prepare
deficiency list from the information received and raise query to the
investigator for missing information and as well as to data management
by using Oracle clinical Remote Data CaptureOCRDC to process the case.
Therapeutic areas: Thrombosis,
. SAE processing and reporting.
. Deficiency list preparation.
. Contacting the trial site
for relevant or missing information.
. Use OCRDC to check the adverse
and other data.
. Raise queries to Investigator
and Data management for missing information.
. Lab Safety data analysis.
. Study Master file maintenance.
Role: Drug Safety Associate
Post marketing support:
The post marketing support was mainly given to the products of the pharmaceutical
company located in Geneva as their headquarters. The main responsibilities
of the Pharmacovigilance team were to do post marketing literature searches
and enter the case into CFR Validated Safety database ARISg
and process the case. Also pro