*.Project/training at LUPIN PHARMACEUTICALS Pvt. Ltd.:
Title: Study of Instruments involved in manufacturing of tablets
Handling of UV spectrometer, HPLC, Tablet Punching machine, Dissolution and disintegration apparatus and Other different operations involved in tablet and capsule manufacturing process
2.Project for final year at RIPER College:
Title: Formulation and Optimization of Famotidine Mucoadhesive Tablets by using Central Composite Design (Sigma-Tech).
Coliforms, tests for pathogens, Biochemical tests.
Languages Proficient: English, Telugu and Hindi.
Hobbies: Playing Badminton and Cycling.
Professional Experience
Working as Safety Science Analyst in Case Processing role at COVANCE
by LABCORP, from Jan/2021 to till date.
Name: P NITISH REDDY
Permanent Address:
Anantapur, Andhra Pradesh,
515004
Mobile: +918*********
Present Address:
Anantapur, Andhra Pradesh,
515004
Email: *************@*****.***
Education
B.Pharm (Bachelor in Pharmacy) from Raghavendra Institute of Pharmaceutical Education and Research, Anantapur, Andhra Pradesh (2016-20) with 8.54 CGPA.
Intermediate
From Sri Chaitanya Junior College, A.P (2014-16) with 93.9%.
Matriculation
From Montessori Eng. Med. School, A.P (2014) with 9.3 GPA.
PROFESSIONAL SUMMARY OF
P NITISH REDDY
Objective:
Experienced in Drug Safety Operations and aiming to earn an entry level statistical job in clinical domain which provides me job satisfaction and self-development and help me achieve personal as well as organizational goals.
Experience in Pharmacovigilance
Assist in the reporting of Expedited Safety Reports(ESRs).
Providing administrative support to PV and DSS personnel.
Ensuring all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/ Senior Drug Safety Associate (Sr.DSA).
Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).
Where applicable, check the PV and DSS hotline mailbox regularly for reported requirements in all countries.
Coordinate shipments of safety documents.
Prepare and coordinate safety study files for archiving at completion of projects.
Arrange and schedule internal and external meetings/teleconferences.
Train and mentor the PV and DSS Support Specialists in their day-to-day activities.
Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
SAS skill set:
SAS/Base, Proc SQL, SAS/Macros and SAS/Advance
Accessing:
Use FORMATTED, LIST and COLUMN input to read raw data files
Use INFILE statement options to control processing when reading raw data files
Use various components of an INPUT statement to process raw data files including column and line pointer controls, and trailing @ controls
Combine SAS data sets using the DATA step
Creating Data Structures:
Create temporary and permanent SAS data sets
Create and manipulate SAS date values
Use DATA Step statements to export data to standard and comma delimited raw data files
Control which observations and variables in a SAS data set are processed and output
Managing Data:
Investigate SAS data libraries using base SAS utility procedures
Sort observations in a SAS data set
Conditionally execute SAS statements
Use assignment statements in the DATA step
Modify variable attributes using options and statements in the DATA step
Accumulate sub-totals and totals using DATA step statements
Use SAS functions to manipulate character data, numeric data, and SAS date values
Use SAS functions to convert character data to numeric and vice versa
Process data using DO LOOPS
Generating Reports:
Generate list reports using the PRINT and REPORT procedures
Generate summary reports and frequency tables using base SAS procedures
Enhance reports through the use of labels, SAS formats, user-defined formats, titles, footnotes and SAS System reporting options
Generate HTML reports using ODS statements
Accessing Data Using SQL:
Generate detail reports by working with a single table or joining tables using PROC SQL and the appropriate options
Generate summary reports by working with a single table or joining tables using PROC SQL and the appropriate options
Construct sub queries within a PROC SQL step
Compare solving a problem using the SQL procedure versus using traditional SAS programming techniques
Demonstrate advanced PROC SQL skills by creating and updating tables, updating data values, working with indexes using the macro interface/creating macro variables with SQL, defining integrity constraints, SQL views and SET operators
Safety Science Analyst
Skills:
SAS Base/ Advance
SAS Macro
Proc SQL
ICH Guidelines
MedDRA Terminology
AE Coding
Strengths:
Willing to take challenging jobs
Punctuality
Good technical knowledge
Time management ability
Handling Errors:
Identify and resolve programming logic errors
Recognize and correct syntax errors
Examine and resolve data errors
Macro Processing:
Creating and using user-defined and automatic macro variables within the SAS Macro Language
Automate programs by defining and calling macros using the SAS Macro Language
Understand the use of macro functions
Recognize various system options that are available for macro debugging and displaying values of user-defined and automatic macro variables in the SAS log
Software/technical skills:
SAS Tools :SAS (Base SAS, Macros, Access, SQL)
Data Access Method :SAS/ACCESS
Operating System : Windows XP, Windows 10
Academic Projects
Other Details