He is a Post graduate in Medicinal Chemistry comes and comes with a good experience in case processing of individual case safety reports. He has varied experience in carrying out Pharmacovigilance activities like triage of incoming cases to determine seriousness for prioritization of daily workflow, processing of cases, medical coding and Narrative writing for investigational and marketed medicinal products.
He has over 4 years of experience in pharmacovigilance and regulatory industry and is currently working as submission reviewer. His responsibilities include perform/oversight safety regulatory reporting (ICSR's) in all major regions.

He is a result oriented health care professional holding a degree of Post Graduate in Pharmacy. He has a rigorous experience of over 8 years in the areas of Pharmacovigilance and Clinical Trials and has worked for reputed companies like ICON, Synowledge and IQVIA.
He has extensive expertise in case processing and quality reviewing of ICSRs, knowledgeable on global Pharmacovigilance reporting methods (single report/aggregate report) execution of PVA's and process error investigations.
He has worked on the major therapeutic areas like Nephrology, Immunology (biologics), Oncology and vaccines for Drug safety operations.
Mr. Mrutunjay also possesses strong expertise on GVP modules and ICH guidelines for Pharmacovigilance.

She is a seasoned professional with overall experience of approximately 9 years in the industry with good exposure to Clinical Research, Pharmacovigilance and Data Management.
She has handled different software like EDC, Oracle Clinical, Oracle AERS, ArisG, Percieve etc.
She has expertise in Narrative writing for multiple clinical trial studies (Renal, Oncology, vaccines etc.) and has worked for industry giants like Quintiles and Accenture.

Ms. Najmun possess more than 9 years of experience in Clinical Research and Pharmacovigilance domain and has worked for companies like Accenture, Synowledge and Quintiles.
She has extensive experience in processing and reviewing clinical trial & Post Marketing cases ranging from a wide therapeutic area (Oncology, CNS, CVS, Acute Inflammatory, Infectious diseases).
She also has expertise in protocol designing and safety monitoring of clinical trials from Phase I to Phase IV.

Ms. Morusupalli, a Post graduate in Pharmaceutical sciences comes, with a good experience in case processing of individual case safety reports.
Ms. Morusupalli has varied experience in carrying out Pharmacovigilance activities like literature searches, Preparation of deviation memo, Database searches, Registry and Triage of incoming cases to determine seriousness for prioritization of daily workflow, request translations as required (forward to LMD as appropriate) and Narrative writing for different trials.

Ms. Mathew is a meticulous and highly accomplished professional with extensive experience in Drug safety.
Her core competency is in case processing of individual case safety reports including follow up of adverse drug reactions. She is also responsible for quality checks of ADR reports received from regional hospital for quality & accuracy.
Ms. Mathew also has experience in conducting hands on training workshops and CMEs on pharmacovigilance. She possess experience in using Vigiflow.

Mr. Bairagi comes with 8+ years of experience in pharmacovigilance operations. His experience includes but not limited to ICSRs identification and processing, Quality review of ICSRs, Training and mentoring.
He has working experience on various databases like ARGUS, ARISg, IRMS, eCTD, GDMS, and SPS etc.
Mr. Bairagi is well experienced in facing client audits and SOP preparation. He was involved in the review serious adverse experience (SAE) reports received from Investigator sites and adverse experiences (AEs) from post marketing sources.
Mr. Bairagi was also part of the Quality review team and was engaged in performing quality control checks of completed individual safety reports to ensure compliance with regulatory reporting requirements. He also has brief knowledge of medical coding, medical writing and clinical data management.

Dr. Kumar is MBBS & MD in Pharmacology having demonstrated the ability to lead diverse activities of Pharmacovigilance and Clinical Research.
Nineteen plus(19+) years of hands-on experience in strategic planning, attainment of quality and financial standards, budget preparation, and overall coordination of Global Pharmacovigilance and Clinical Research operations.
Implemented, Validated and Established global safety databases like ARGUS, ARISg for Multiple Global Pharma organizations. Developed from scratch, an E2B compliant end to end safety databases like PvNET and IPS (Proprietary safety database of TCS).
He has worked with several global organizations on Senior Pharmacovigilance positions, including Global Pharmacovigilance Head, Cognizant Technologies; Vice President Lambda Therapeutics; Group Leader – Pharmacovigilance, Ranbaxy; Head Global Pharmacovigilance at Aurobindo and Panacea.

Mrs. Stephy is an experienced professional with more than 3 years of experience in data management and over 1 year experience in clinical research. In her current role she performs quality review of SAS data sets and reconciliation of data
Prior to her role in data management she managed clinical trials from start up to close out stage for various indications and has a sound knowledge of ICH GCP and Indian regulatory environment.

Ms. Ali is a young, enthusiastic data management professional with more than 4 years of working experience in the domain. She has thorough knowledge and specialisation in different activities with study setup,maintenance and conduct phases in different databases.
She has a good command over discrepancy management and data cleaning activities and has extensive exposure of clinical databases Rave, Oracle Clinical, Inform 4.6 and Inform 5.5
She comes with vast experience in different Clinical Research Therapeutic Areas including Oncology, Alzheimer, Antidepressant studies, Rheumatoid Arthritis, Malignant Breast Tumour, Ulcerative Colitis, Allergy, HIV Infection etc.

Mr. Lokesh is a meticulous, goal-oriented, experienced data management professional with over 5 years of experience in the domain with a strong commitment to the field of research.
He also has a hard core experience in the field pf Clinical Research with thorough understanding & knowledge in Clinical Operations, Site Operations and regulatory process. He also supports eTMF department and is well versed with end to end processing of documents.
He bears the skill set to ensure high quality data and on-time completion of complex projects.

He is a result oriented professional with rigorous experience of over 13 years in the areas of Clinical Research and Data Management. He is presently spearheading as a Protocol Data Manager. Prior to his role as a Manager he was the Lead Data Manager for NIH-International Centers for Excellence in Research.
He has an excellent skill set in managing clinical trial data and providing data management support to Clinical Operations, data management & Biostatistics team.
Mr. Balakrishnan has extensive knowledge in all areas of research including budgeting, GCP, IRB, Submissions & Safety reporting.

Life Sciences and Healthcare Management Consultant with 11 years of experience in pharma business analytics and clinical research Industry. Worked at managerial positions in leading pharma consulting companies like WNS Global Services and Smart Analyst Private Limited, expertise in competitive intelligence, epidemiology, current treatment landscapes, clinical trial analysis, pipeline analysis, primary and secondary market research, oncology conference coverages, pharma shots, company page profiling and hands-on experience on clinical databases like Pharmaprojects, Trial Trove, Adisinsight, Medline, PubMed, Clinicaltrials.gov, EudraCT, Japic clinical trials.
Subject matter expert for Oncology, Immuno-Oncology therapy area with knowledge of various solid tumors and Hematological malignancies. Expertise in planning, quality check, end to end client deliveries along with team management, project management and client engagement skills.
Masters and Bachelors in Pharmaceutical Sciences from DIPSAR, Delhi University along with completion of post graduate courses in Pharmaceutical Drug Regulatory Affairs (Jamia Hamdard), Clinical Research and Patents.

An M.Pharm (Pharmacology) by training with over 15 years’ experience in Clinical Research specializing in the areas of Project Management, Quality Management, GCP / GxP Audits, Sponsor liaising, People Management, GCP and regulatory training, Site training and development, SOPs creation and up gradation etc. Worked with leading Indian and multinational companies viz. Clintec, Cliniminds, CRQA, Cytespace, Panacea Biotec.
Experience in the following therapeutic areas - Dermatology, Oncology (Breast Cancer, Hodgkin’s (NHL), Colorectal cancer, Rheumatoid Arthritis, Pain Management, Hemorrhoids, Dermatology, Pulmonology( Upper Respiratory Tract Infections).

A PhD statistician with more than 13 years of overall experience in statistical research, university teaching, data analysis, data interpretation and report writing.Expertise in:
Protocol Inputs
Sample Size Calculation
Simulation
Statistical Modeling
Survival Analysis
Supporting DSMB related activities
Writing Statistical Analysis Plans and Creating Mock Shells
Exploratory Analyses
Bayesian Statistics
SAS and R programming Languages
Training Expertise:
Extensive training experience in Basis as well as Advanced Statistics and R programming