Quality Control

Objective

ABSTRACT Seeking a challenging career in an organisation which

PASSIONATE PHARMACOVIGILANCE & offers ample opportunities in the field of

DRUG SAFETY PROFESSIONAL WITH Pharmacovigilance/Drug Safety and Clinical Research.

COMPREHENSIVE EXPERIENCE IN Enormous passion to innovate, create and play a

INDIVIDUAL CASE SAFETY REPORTS significant role in the growth of the organisation by

(ICSRS) FOR MORE THAN 4 YEARS utilising my professional skills and work experience. To

COUPLED WITH 2 YEARS OF associate myself to an organization and work for safety

CLINICAL EXPERIENCE IN of the patients.

DENTISTRY AND DENTAL

THERAPEUTICS. KNOWLEDGE OF Professional Summary (Global Pharmacovigilance &

PERIODIC SAFETY UPDATE REPORTS Epidemiology)

(PSURS) AND PERIODIC ADVERSE

DRUG EXPERIENCES REPORT Comprehensive knowledge in handling Individual Case

(PADERS). Safety Reports (ICSRs). Gained experience and expertise

in handling ICSRs pertaining to Oncology, Central Nervous

Professional Accolades in System, Cardiovascular System, HIV and Anti-Infective

Accenture Pharma Services therapy.

(Client: Global Knowledge of 21 CFR Parts 11/314/20, Volume 9 A, MHRA

Pharmacovigilance & best practices, CIOMS guidelines and ICH recommendations.

Epidemiology of US based

pharmaceutical company) Well versed with regulatory requirements and reporting

timelines for submission of Serious Adverse Events and

JAN-2010-PRESENT Adverse events to FDA, MHRA and EMEA.

Process Lead-Quality Hands-on experience in MedDRA and knowledge of ICD coding

Monitoring, Standards and & various Thesaurus Management Systems.

Training Identified and handled Suspected Unexpected Serious

Adverse Reaction reports (SUSARs) for Investigational

JUN-2009 to JAN-2010 Medicinal Products (IMPs) and Comparators.

Global Quality Monitoring Provided inputs for documenting Standard Operating

Specialist & Subject Matter Procedures (SOPs) and Work Practices (WPs). Amendments

Expert were recommended when needed to comply with regulatory

requirements.

MAR-2008 to JUN-2009 Managed training of new recruits: Trained resources for

Subject Matter Expert in Drug Drug Safety, Case Processing & Quality Control for

Safety handling the job role of Drug Safety Specialist and

Quality Monitoring.

Apr-2007 to Mar-2008 Trained Medical Review Safety Physicians on drug safety

Drug Safety Reviewer/Associate aspects of ICSRs and MedDRA coding.

As a senior Process Lead, mentored subject matter experts

for conducting training for new resources.

Dentistry Organized quality work shops and created Quality Circles

Oct-2006 Feb-2007 to improve the quality of Individual Case Safety Reports

Jai Sai Dental Hospital, (ICSRs).

Chennai Efficiently managed a team of Drug Safety Associates and

Subject Matter Experts.

Oct-2005 to Oct-2006 Audits: Participated in several internal and external

Sri Hari Dental Hospital. audits to check for appropriate controls in the process.

Documented audit findings and helped in establishing

Oct-2005 to Oct-2006 guidelines for being compliant with data protection laws

Internship: Govt., Dental and regulations.

College &

Hospital, Chennai

Special Projects

Database Up-gradation

Professional Qualifications Participated and lead the offshore team in "User

Acceptance Testing Program" for testing the new version

2007-2009 of adverse event capturing database. Provided inputs and

Master of Business suggested solutions to solve issues related to Electronic

Administration (MBA) Submission of ICSRs and generation of E2B compliant

Operations and Marketing reports.

Anna University (CDE), Engaged myself in workshops and knowledge transfer

Chennai, India programs at the onshore site.

Total Average Score: 75% Played an indispensible role in training resources to

work on the Up-graded database and in successful

2001-2006 implementation of the newer version in a very short time

Bachelor of Dental Surgery span, which was well appreciated.

(BDS) Managed and performed Study Un-blinding, Data

Government Dental College, Dr. re-conciliation & and other ad-hoc Projects.

MGR Medical University, Productivity Improvement Task Force: Increased individual

Chennai, India productivity by eliminating redundant processes and by

Total Average Score: 68% sharing best practices for delivering high quality

coupled with high productivity. Thereby overall

1999-2001 production and quality increased by 18% in Jan-2011.

Schooling Higher Secondary Quality Monitoring

(High School) Sampled and reviewed ICSRs processed by both onshore and

SBOA School, Chennai, India offshore team for consistency, quality and accuracy of

Total Average Score: 95% information.

Documented and analyzed the trends in errors and provided

1998-1999 corrective and preventive action (CAPA).

Secondary School Examination Identified Training needs and conducted refresher

SBOA School, Chennai, India trainings.

Total Average Score: 87% Handled dual role of Quality Monitoring and Drug Safety

Subject Matter Expert.

Quality Monitoring of Special Cases and Target Areas:

Monitored quality of target areas like Pregnancy and

Literature Reports to improve the quality of the

Computer Skills information provided in these cases.

System driven Quality control checks were suggested in

COURSE: NIIT SWIFT the database, and implementation of which improved the

MICROSOFT OFFICE-EXCEL, WORD, overall quality of reporting ICSRs.

PUBLISHER, POWERPOINT, PDF AND

XML EDITORS. Soft Skills

Communication: Ability to convey intended meaning that

Knowledge of Oracle Clinical, can be understood by others, to instill thoughts that

Clintrace, Argus and SAS result in desired responses or actions. Keen listener and

Databases. Basic C++ and Basic served a single point of contact between the clients and

Programming. Macros in MS the offshore team.

office

Team Player: Crafted and created a group of highly

valuable resources through good interpersonal

relationship. Took part in various team building

activities organized by Pegasus Institute of Excellence,

Pondicherry, India.

Leadership and Motivation: Ability to negotiate the right

Accomplishments path through a people centric approach to meet business

standards and deadlines. Served as a mentor and motivated

Won Good Samaritan Award for people for high performance.

the year 2008 and 2009 for

developing people. Conflict Management: Proactive in identifying potential

Awarded Numero-Uno of the year problems and deriving various solutions. Solution

2009 -2010 for value creation oriented approach in handling situations has always

and leadership abilities. helped in understanding the root cause of the issues and

Whizkid award for technical wholesome corrective and preventive actions

intelligence in the process in

the year 2010 Interests:

Twice rated as "Top of the Clinical Research, New Molecule Discovery, Scientific

Peer Group" in Performance Literature and New Treatment Modalities.

Appraisal. (Feb-2009; Clinical Databases/Pharmacovigilance systems, SAS/ Oracle

Feb-2010) Clinical Programming, E2B essentials for Drug Safety.

Conducted and provided inputs

for training sessions for Volunteer Experience

students of reputed Volunteered for several Medical and Dental camps as part

institutions providing courses of Corporate Social Responsibility programs.

on Clinical Research (ICRI Created awareness programs for health professional

Bangalore India) regarding reporting of adverse events/reactions in India.

Won the "Deal Star" award in

2011. Participated in Tsunami victims' rehabilitation program

An extract of the appreciation in India.

note from the clients (Project Hobbies:

Director) TREKKING, SKIING, CARPENTRY, PHOTOGRAPHY AND ADVENTURE

solution oriented and SPORTS.

always open and honest yet

respectful; truly a pleasure Languages:

to work with Mar-2011) ENGLISH : FULL PROFESSIONAL PROFICIENCY (PASSED

OCCUPATIONAL ENGLISH TEST (OET-2008) CONDUCTED

Licenses and Certificates BY DENTAL COUNCIL OF AUSTRALIA)

MEMBER OF INDIAN DENTAL

ASSOCIATION. French : Basic proficiency (Reading and Writing)

Licensure: Dental Council of

India (Lifetime License) Indian Languages: Tamil and Hindi

Member of Pharma Academy of

Excellence (Accenture) Onshore Projects/Programs

Certified as Life Science FEB 2009: "KNOWLEDGE TRANSFER" AND "TRAIN THE TRAINER"

Industry Generalist By PROGRAM

Accenture Feb-2011: Database Up gradation - "User Acceptance

Testing Program"

Visa Status: US Business visa (B1/B2) valid till 2019.

PERSONAL DETAILS:

DOB : 20-NOV-1983

Sex : Male

Citizenship : Indian

Marital Status : Single

Dr.Karthik Muthusamy bds., mba

Drug safety and pharmacovigilance specialist

*******.*.**@*****.***

*******.*.**@*****.***, ************@*****.***

Ph: +91-917*******/ 988-***-****

Postal Address: No.33/1, New No. 80, Mosque Street, Saidapet West, Chennai

- 600015, Tamil Nadu, India.

Contact this candidate