*.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: adnx3n@r.postjobfree.com

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

Contact this candidate