Ananda Sasmal

• Performed ICSR case processing in ARISg and agExchang for AE reporting based on the United States
• Conducted case processing of Spontaneous, Solicited, Literature spontaneous and other reports for dugs, vaccines as well as combination products
• Collaborated with other Safety analysts to analyze, review, and evaluate the report for submitting the report with high quantities and qualities.

• Performed ICSR case processing in Argus for AE reporting based on the United States
• Conducted case processing of Spontaneous, Solicited, Literature spontaneous and other reports for dugs, vaccines as well as combination products
• Processed ICH invalid cases
• Collaborated with other Safety analysts to analyze, review, and evaluate the report for submitting the report with high quantities and qualities
• Promoted to Interim Quality Analyst after six months working as a Case Processor.

• Collaborated with the company‟s Scientist team to develop their approaches for their research work
• Created mockups and prototypes to strengthen design and improve scientific work
• ANDA and NDA application for market approvals as per USFDA, EMEA and other guidelines
• Reviewed Literature, evaluated design, modeled protocol, conducted scientific study, Summarized results and conclude the study with organized manner.

• Always in touch with Company‟s employee to understand the Manufacturing of a pharmaceutical product according to GLP guidelines
• Evaluated the manufacturing procedure and accurate documentation of the process
• Examined the Receiving, Dispensing, Production, Quality controlling and Dispatching of the finished products as per guidelines
• Identified the whole process for conduction of a USFDA approved manufacturing plant and working principles
• PROJECTS
• Bioequivalence Study of Pramipexole Dihydrochloride Monohydrate 0.18 Mg Tablet Versus ‘Sifrol ’ 0.18
• Mg Tablets in Healthy Adult Subjects Under Fasting Conditions: A Randomized, Open-Label, Two-Way
• Crossover Study
• The work reported in the thesis has been carried out by me under mutual collaboration with Zydus-Cadila

GPA: 7.02, Major Project – “Bioequivalence Study of Pramipexole Dihydrochloride Monohydrate 0.18 Mg Tablet Versus „Sifrol, 18 Mg Tablets in Healthy Adult Subjects Under Fasting Conditions: A Randomized, Open-Label, Two-Way Crossover Study” Major Project Advisor – Prof. Dr. Rahul Desmukh

• Awarded [Innovation Parma Writing]

Marks: 78.80%

Marks: 74%