CURRICULUM VITAE
PERSONAL INFORMATION Venkatesh Kumar Gurusamy
WH Aristotelessteig 2, 10318, Berlin
(+49-152) 19385608
gvenkysrmc@gmail.com
Sex Male | Date of Birth 05 September 1978
Nationality Indian
PRIOR DESIGNATION
PROFESSIONAL SUMMARY
March 2016-Aug 2016
Nov 2015-Jan 2016
Apr 2015-Oct 2015
Apr 2011–Oct 2013
Dec 2008–Apr 2011
May 2007–Dec 2008
July 2002–May 2007
Clinical Safety Scientist/Drug Safety Associate
Master Thesis at Global Epidemiology (Bayer Pharma AG, Berlin)
Thesis topic: Association between socioeconomic factors and access to newly marketed drugs
and standard of care in the Swedish population.
Intern at Quantitative Safety & Epidemiology (Novartis AG, Basel)
▪ Assisting epidemiologists in safety signal evaluation, developing safety risk management
strategy and conducting non-interventional studies
▪ Reviewing the literature, performing simple analyses in cancer registries and summarizing
epidemiologic information on safety risks and diseases including comorbidities
▪ Created a database on “Novartis Clinical Trials Database for Contextualization”
Intern at Global Epidemiology (Bayer Pharma AG, Berlin)
▪ Performed systematic review on Drug Induced Liver Injury; Hepatocellular, Cholestatic &
Mixed liver injury; Liver failure; Liver function test abnormal
▪ Prepared epidemiological sections in RMP and dRMP
▪ Generating literature reviews using best practice methodologies to evaluate published
evidence
Clinical Safety Scientist / Literature Coordinator
Company: Accenture Pharma Services; Client: Novartis AG, (Basel)
▪ Team leader and process trainer for literature search and literature review activities
▪ Quality Reviewer and case processor of Initial and Follow-up ICSR’s in ARGUS 7
▪ Performed Triage, MedDRA coding, WHO coding, narrative writing and case assessment
regarding listedness for Initial and Follow-up ICSR’s (Serious and Non-serious)
▪ Good knowledge in PSUR, Aggregate safety reports, GVP Modules, ICH GCP and Drug Safety
Guidelines E2B
Drug Safety Associate/Quality Reviewer
Accenture Pharma Services; Client: Solvay Pharmaceuticals, (Germany)
▪ Quality reviewer for Initial and Follow-up ICSR’s
▪ Case processor for Spontaneous, Clinical Trial, Literature and Regulator Authority ICSR‘s in
Clintrace
▪Query initiation to Medical Reviewer, completion of Case Workflow Sheet, implementation of
recommendations from medical reviewer and initiation of the follow- up and closure of the case
Clinical Data Validation Expert
Accenture Pharma Services; Client: Wyeth Pharmaceuticals, (USA)
▪ Ensuring completeness and validity of the clinical trial data in Oracle Clinical and in EDC
▪ Query generation, handling, editing, tracking and issuing Data clarification form (DCF)
▪ Supporting the Clinical Trial Management in critical areas such as regulatory submission and
approval, medical writing, therapeutic training to the Clinical operations and study team
Physiotherapist
Vignan Physiotherapy & Pain Relief Clinic | Indian Red Cross Society
▪ Patient assessment and diagnosis followed by treatment planning & implementation. Devising
individualized treatment plan. Coordinating with other members in the interdisciplinary team
EDUCATION & TRAINING
Oct 2014–Till date
Jan 2002–Jun 2002
Aug 1997– Jun 2002
Certifications
Process Training
Publications
PERSONAL SKILLS
Language proficiency
Master of Science (Epidemiology)
Ludwig Maximilian University
▪ Quantitative methods, Epidemiology & Research Design, Clinical Epidemiology,
▪ Recent developments and Biostatistics, Global Public Health, Health Service Research
▪ Advanced Epidemiology (Pharmacoepidemiology, Cancer & Cardiovascular Epidemiology)
▪ Profound knowledge in Observational and Experimental studies
▪ Good proficiency in using statistical tool ‘R’ and SAS
Diploma in Research Methodology and Bio-Statistics
Association of Professional Psychologists (India)
▪ Introduction to Research Methodology, hypothesis testing
▪ Experimental design, variables and control
▪ Methods of Data Collection, Correlational Strategies, Parametric and non-Parametric tests
▪ Organization and Graphical Representation of Data
Bachelor of Physiotherapy
Sri Ramachandra Medical College & Research Institute (India)
▪ Anatomy, Physiology, Biochemistry, Pathology, Microbiology, Pharmacology
▪ General Medicine, General Surgery, Pediatrics, Clinical Nutrition
▪ Clinical Neurology, Orthopedics and Cardiology
▪ Rehabilitation medicine, Physiotherapy in Neurology, Orthopedics,
▪ 2011: Argus end user training
▪ 2009: Clintrace end user training
▪ 2002: Certificate of membership-The Indian Association of Physiotherapist
▪ 2012: Literature Search Tool (LiSA) training for literature search, review and signal detection
▪ 2012: Clinical Safety Scientist training-quality review of serious and non-serious cases
▪ 2009: MedDRA coding training
▪ 2007-Study Data Management-Data Entry, Data Validation, Query management for
Paper based and EDC studies
▪ Abstract on “Review of current treatment patterns in patients treated long-term for branch
retinal vein occlusion (BRVO)”
▪ Abstract on “Novartis Clinical Trials Database for Contextualization”
▪ English-fluent
▪ German-A2 level
▪ Tamil-Native language
Communication Skills ▪ Team Management
▪ Sound knowledge in conflict management and facilitation techniques
Organization and Managerial ▪ Experience in team and project management
Skills
Computer Knowledge ▪Profound knowledge in Microsoft Office Tools
Declaration
I hereby confirm that all information declared above is true to the best of my knowledge and belief.

Venkatesh_CV

  • 1.
    CURRICULUM VITAE PERSONAL INFORMATIONVenkatesh Kumar Gurusamy WH Aristotelessteig 2, 10318, Berlin (+49-152) 19385608 gvenkysrmc@gmail.com Sex Male | Date of Birth 05 September 1978 Nationality Indian PRIOR DESIGNATION PROFESSIONAL SUMMARY March 2016-Aug 2016 Nov 2015-Jan 2016 Apr 2015-Oct 2015 Apr 2011–Oct 2013 Dec 2008–Apr 2011 May 2007–Dec 2008 July 2002–May 2007 Clinical Safety Scientist/Drug Safety Associate Master Thesis at Global Epidemiology (Bayer Pharma AG, Berlin) Thesis topic: Association between socioeconomic factors and access to newly marketed drugs and standard of care in the Swedish population. Intern at Quantitative Safety & Epidemiology (Novartis AG, Basel) ▪ Assisting epidemiologists in safety signal evaluation, developing safety risk management strategy and conducting non-interventional studies ▪ Reviewing the literature, performing simple analyses in cancer registries and summarizing epidemiologic information on safety risks and diseases including comorbidities ▪ Created a database on “Novartis Clinical Trials Database for Contextualization” Intern at Global Epidemiology (Bayer Pharma AG, Berlin) ▪ Performed systematic review on Drug Induced Liver Injury; Hepatocellular, Cholestatic & Mixed liver injury; Liver failure; Liver function test abnormal ▪ Prepared epidemiological sections in RMP and dRMP ▪ Generating literature reviews using best practice methodologies to evaluate published evidence Clinical Safety Scientist / Literature Coordinator Company: Accenture Pharma Services; Client: Novartis AG, (Basel) ▪ Team leader and process trainer for literature search and literature review activities ▪ Quality Reviewer and case processor of Initial and Follow-up ICSR’s in ARGUS 7 ▪ Performed Triage, MedDRA coding, WHO coding, narrative writing and case assessment regarding listedness for Initial and Follow-up ICSR’s (Serious and Non-serious) ▪ Good knowledge in PSUR, Aggregate safety reports, GVP Modules, ICH GCP and Drug Safety Guidelines E2B Drug Safety Associate/Quality Reviewer Accenture Pharma Services; Client: Solvay Pharmaceuticals, (Germany) ▪ Quality reviewer for Initial and Follow-up ICSR’s ▪ Case processor for Spontaneous, Clinical Trial, Literature and Regulator Authority ICSR‘s in Clintrace ▪Query initiation to Medical Reviewer, completion of Case Workflow Sheet, implementation of recommendations from medical reviewer and initiation of the follow- up and closure of the case Clinical Data Validation Expert Accenture Pharma Services; Client: Wyeth Pharmaceuticals, (USA) ▪ Ensuring completeness and validity of the clinical trial data in Oracle Clinical and in EDC ▪ Query generation, handling, editing, tracking and issuing Data clarification form (DCF) ▪ Supporting the Clinical Trial Management in critical areas such as regulatory submission and approval, medical writing, therapeutic training to the Clinical operations and study team Physiotherapist Vignan Physiotherapy & Pain Relief Clinic | Indian Red Cross Society ▪ Patient assessment and diagnosis followed by treatment planning & implementation. Devising individualized treatment plan. Coordinating with other members in the interdisciplinary team
  • 2.
    EDUCATION & TRAINING Oct2014–Till date Jan 2002–Jun 2002 Aug 1997– Jun 2002 Certifications Process Training Publications PERSONAL SKILLS Language proficiency Master of Science (Epidemiology) Ludwig Maximilian University ▪ Quantitative methods, Epidemiology & Research Design, Clinical Epidemiology, ▪ Recent developments and Biostatistics, Global Public Health, Health Service Research ▪ Advanced Epidemiology (Pharmacoepidemiology, Cancer & Cardiovascular Epidemiology) ▪ Profound knowledge in Observational and Experimental studies ▪ Good proficiency in using statistical tool ‘R’ and SAS Diploma in Research Methodology and Bio-Statistics Association of Professional Psychologists (India) ▪ Introduction to Research Methodology, hypothesis testing ▪ Experimental design, variables and control ▪ Methods of Data Collection, Correlational Strategies, Parametric and non-Parametric tests ▪ Organization and Graphical Representation of Data Bachelor of Physiotherapy Sri Ramachandra Medical College & Research Institute (India) ▪ Anatomy, Physiology, Biochemistry, Pathology, Microbiology, Pharmacology ▪ General Medicine, General Surgery, Pediatrics, Clinical Nutrition ▪ Clinical Neurology, Orthopedics and Cardiology ▪ Rehabilitation medicine, Physiotherapy in Neurology, Orthopedics, ▪ 2011: Argus end user training ▪ 2009: Clintrace end user training ▪ 2002: Certificate of membership-The Indian Association of Physiotherapist ▪ 2012: Literature Search Tool (LiSA) training for literature search, review and signal detection ▪ 2012: Clinical Safety Scientist training-quality review of serious and non-serious cases ▪ 2009: MedDRA coding training ▪ 2007-Study Data Management-Data Entry, Data Validation, Query management for Paper based and EDC studies ▪ Abstract on “Review of current treatment patterns in patients treated long-term for branch retinal vein occlusion (BRVO)” ▪ Abstract on “Novartis Clinical Trials Database for Contextualization” ▪ English-fluent ▪ German-A2 level ▪ Tamil-Native language Communication Skills ▪ Team Management ▪ Sound knowledge in conflict management and facilitation techniques Organization and Managerial ▪ Experience in team and project management Skills Computer Knowledge ▪Profound knowledge in Microsoft Office Tools Declaration I hereby confirm that all information declared above is true to the best of my knowledge and belief.