Job Training Services

Job Training Services to Help Employees and Employers

ACI training Center provides Job Trainings to Fresher and Working Professionals to help them in advancing their career using personalized counseling and skill assessment sessions followed by Job Specific Training and skill development sessions by Industry Professionals.

ACI has counseled and trained many candidates nationally and internationally till date. Our trainer’s teams have additionally developed very effective modules specializing in the professional as well personality development trainings.

Our training programs make graduates job ready with some of the common but important skills necessary to successfully enter in the fields of Pharmacovigilance and Clinical research.


Explore our below Job training programs and get ready for the job

This is a Job Training Program for Pharmacovigilance Scientist and you will be engaged in the practical operation of pharmacovigilance like case processing, regulatory reporting as per industry setting.

This training program provides in-depth knowledge and practical exposure to roles and responsibilities of Pharmacovigilance Scientist.

PROGRAM HIGHLIGHTS
ELIGIBLITY Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics)   and all professionals working with Pharmaceutical companies, CROs and Hospital.
BUSINESS STREAM INDUSTRIES:Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO
DURATION:8 Weeks
TRAINING CONTENT WEEK 1 — THE THEORY AND PRACTICE OF PHARMACOVIGILANCE: Sessions: Drug Development Process, Introduction to Pharmacovigilance, Pharmacovigilance Terminologies Practice: Cases to differentiate AE/ADRs, Serious/Non-Serious, Valid/Non-Valid
WEEK 2 – CASE PROCESSING IN PHARMACOVIGILANCE Sessions:  Introduction to ADRs - Spontaneous adverse reaction reporting, developing an ADR reporting culture - methods, design, medical content and the importance of reporting, Effective communication in PV, Case Triage and Follow ups, Causality assessment Practice: Cases to do triage, Causality assessment
WEEK 3 – REPORTING IN PHARMACOVIGILANCE Sessions:  Training on Narrative writing, Expedited Reporting, PSUR/DSURs, Signal Management Practice: Cases to do narrative writings
WEEK 4 - REGULATORY ASPECTS OF PV Sessions:  Regulatory guidelines – ICH, GVP, 21CFR, Schedule Y and CIOMS Practice: Cases for complete processing
WEEK 5 – PHARMACOVIGILANCE CASE PROCESSING ON ARGUS SAFETY 7.0 Sessions:  Introduction to safety databases, Hands on sessions on recording ICSRs, ICSR-Assessment, Data entry and retrieval from ICSR databases, Duplicacy check, Case Bookin Practice: Cases to check Duplicacy and Initial case entries
WEEK 6 – COMPLETE CASE PROCESSING ON ARGUS SAFETY 7.0 Sessions:  Case entries in General, Patient, Product, Event and Analysis tabs, MedDRA coding, WHO-DD coding Practice: Cases for complete case entries
WEEK 7-8 – PRACTICE ON REAL TIME CASES >20 cases will be given to process starting from Validity check, Triage, Case entries, Causality assessment and Narrative writing

Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials. Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course comprises theory and practical sessions, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications.

This training will provide extensive training in the niche domain of clinical data management. It incorporates end-to-end theoretical & practical training sessions on Oracle Clinical, Remote Data Capture (RDC) & Oracle Inform Central Designer.

PROGRAM HIGHLIGHTS
ELIGIBLITY Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
BUSINESS STREAM INDUSTRIES:Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO
DURATION:8 Weeks
TRAINING CONTENT Following Course Content will be covered during the training:
  • Welcome and Introduction to Clinical Data Management
  • Drug Development and Clinical Trial Phases
  • Fundamentals of Clinical Research & Roles in a CRO
  • Clinical Data Management Process & Life cycle
  • ICH – GCP guidelines
  • GCDMP guidelines
  • Paper Vs Electronic Data capture
  • Data Management Plan document
  • Introduction to CDISC SDTM Standards
  • Application of SDTM Standards.
  • Clinical Study Documentations Setup
  • CRF Annotation
  • Creation of SDTM annotated CRF
  • Creation of Database Structure Document
  • Creation of Edit Check Specification Documents
  • Study User Acceptance Test (UAT) documents
  • Project Initiation
  • CRF Design/ eCRF design
  • 21 CFR Part 11 Regulations
  • Questions and Discussions
With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development. Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market.

This course will provide extensive training in the niche domain of clinical research. It incorporates end-to-end theoretical & practical training.

PROGRAM HIGHLIGHTS
ELIGIBLITY Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:
Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
BUSINESS STREAM INDUSTRIES:Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO
DURATION:8 Weeks
TRAINING CONTENT Following Course Content will be covered during the training:
  • Drug discovery and development
  • Preclinical studies
  • Basics of Clinical Trials & Clinical Research
  • Terminology & Definitions in Clinical Trials
  • Types and Phases of Clinical Trials
  • Good Clinical Practices (GCP)
  • BA/BE Studies
  • Research Methodology & Clinical Trial Design
  • Clinical Trial Regulatory Affairs
  • Preparations & Planning for Clinical Trials
  • Essential Documentation in Clinical Trials & Regulatory Submissions
  • Clinical Trial Operations and Monitoring
  • Responsibilities of Clinical Research Professionals
  • 21 CFR PART 11
  • Informed Consent Document
  • Schedule Y
  • Protocol Development
  • Intellectual property Rights (IPR) and Patent Laws
  • SOP development for Clinical Trial Operations
  • Compliance, Auditing & Quality Control in Clinical Research

This training program is designed to train the students or professionals to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials. This will give a competitive edge to your skills and you can easily get entry in pharmaceutical, biotechnology, and contract research organization industries as BIOSTATISTICIAN

PROGRAM HIGHLIGHTS
ELIGIBLITY Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:
Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
BUSINESS STREAM INDUSTRIES:Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO
DURATION:6 Weeks
TRAINING CONTENT Following Course Content will be covered during the training:

MODULE 1: Introduction to Clinical Trials and Data Management

MODULE 2: Introduction and Review of Basic Statistics

MODULE 3: Estimation and Precision

MODULE 4: Basic Statistical Tests

MODULE 5: Equivalence and Non-Inferiority Studies

MODULE 6: Beyond Simple Linear Regression and Correlation

MODULE 7: Event-rate Analysis

MODULE 8: Time-to-Event (Survival) Analysis

MODULE 9: Power and Sample Size Calculations (Part 1 -- Concepts)

MODULE 10: Power and Sample Size Calculations (Part 2 – Practical Guide)

MODULE 11: Clinical Trial Design

MODULE 12: Introduction to Bayesian Statistics

MODULE 13: Pharmacokinetics and Pharmacodynamics

MODULE 14: SAS Training (4 Weeks)

MODULE 15: Practical Assignments on Live Projects (2 Weeks)

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use, and other medical information. The medical writer also ensures that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.

A very good opportunity for Science, Medicine & Pharmacy Graduates. If your Basic English is good & you are well versed with medical terminologies, this is one of the fastest growing Service Industry in India.

PROGRAM HIGHLIGHTS
ELIGIBLITY Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. You can Join Regulatory or Commercial Medical writing team in Pharma Companies or CROs or KPOs.
BUSINESS STREAM INDUSTRIES:Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO
DURATION:8 Weeks
TRAINING CONTENT Following Course Content will be covered during the training:
  • Introduction to Scientific/ Medical writing
  • Publication writing
  • Branding and commercial writing
  • Narrative Writing
  • Introduction to regulatory writing
  • Documents in Clinical Research
  • Documents in Medico Marketing
  • Protocol writing
  • PAPER CRF Preparation
  • Investigator Brochure (IB) preparation & Subject Diary Card Preparation
  • Clinical Study Reports (CSR)
  • Common Technical Document (CTD/eCTD) preparation
  • Dossier submissions (IND/NDA/ANDA)
  • ICD translations
  • Handling Statistics in Medical Writing
  • Effective Literature Search
  • Legal/ Copyright Issues in Medical Writing

With so many challenges facing the industry – pricing and pipeline pressures, patent expirations, soaring drug development costs, etc. – a life sciences company’s strength, as well as the intellectual property it needs to improve the health of the public, is being threatened. SAS®, the industry leader in business analytics, assures accurate, consistent and reliable analysis of biopharmaceutical data and information. SAS is the choice of 100 percent of the FORTUNE Global 500® Pharmaceutical companies for Statistical Analysis.

This training will provide end-to-end theoretical & practical training sessions on SAS 9.3 including Base SAS, Advance SAS & Clinical SAS Project. Candidates experienced in this field are usually in very high demand and they command premium salaries. Due to lack of quality professionals, any pharmaceutical company or CRO’s are always on the lookout to hire candidates with skills in the SAS 9.3 with Clinical domain Knowledge.

PROGRAM HIGHLIGHTS
ELIGIBLITY Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. Must possess a Graduate, Post Graduate or Ph D Degree in Statistics, Mathematics, Engineer (All), B.Com/M.Com, BBA/MBA, BCA/MCA, Life Sciences (All), Pharmacy (All), Bio Informatics, Bio Technology, MBBS/BDS .
BUSINESS STREAM INDUSTRIES:Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO
DURATION:12 Weeks
Software used for training : SAS 9.3
TRAINING CONTENT Following Course Content will be covered during the training:

Module 1: INTRODUCTION

  • Welcome and Introduction
  • Drug Development and Clinical Trial Phases
  • Fundamentals of Clinical Research & Roles in a CRO
  • Introduction to SAS in Clinical Data Management.
  • Clinical Data Management Process & Life cycle
  • Importance of CDISC SDTM in Clinical SAS
  • CDISC SDTM Introduction & Standards.
  • Clinical SAS Programmer Roles & Responsibilities
  • Overview of good clinical practice(GCP)
  • What is a protocol?
  • What is informed consent?
  • What is a placebo?
  • What is a control or control group?
  • What are the different types of clinical trials?
  • Different types of reports generated by programmer in clinical trials?

Module – 2: BASE SAS:

  • Introduction To SAS System & Architecture
  • History and Various Modules
  • Features
  • Variables & SAS Syntax Rules
  • SAS Data Sets
  • Data Set Options
  • Operators
  • If – Then Else Statement
  • Where Statement
  • Creating & Redefining Variables
  • Reading Raw Data
  • Infile Statement with Options
  • Multiple Observations and Multiple Datasets.
  • Input Styles
  • SAS Functions
  • Select Statement
  • Do Loops
  • Leave and Continue Statement s
  • Output Statement & Put Statement
  • Stop and Error Statement s
  • Array Statement
  • Modifying and Combining Data Sets
  • Updating Master Data Set
  • Key Board Macros & Add Abbreviations
  • Display Manager Commands

BASE SAS PROCEDURES

  • Proc Sort
  • Proc Print
  • Proc Means
  • Proc Freq
  • Proc Plot
  • Proc Chart
  • Proc Compare
  • Proc Copy
  • Proc Summary
  • Proc Append
  • Proc Datasets
  • Proc Contents
  • Proc Delete
  • Proc Format
  • Proc Printto

SAS/REPORTS:

  • Frequency Report
  • One-Way Frequency Report
  • Cross Tabular Frequency Report
  • Summary Statistic s
  • Creating A List Report
  • Define Statement
  • Order Usage and Group
  • Printing Grand Totals
  • Rbreak Statement
  • Tabulate Procedure
  • One-Dimensional Tables
  • Two-Dimensional Tables
  • Obtaining A Total
  • Analysis Variables with options
  • Summary Statistics

SAS/ODS:

  • Creating Rtf File
  • Creating Html File
  • Creating Pdf File
  • Creating Xml File

MODULE –3: ORACLE-SQL CONCEPTS

  • Introduction
  • History
  • Features
  • Sql Command Set
  • Operators In Sql
  • Order By Clause
  • Group By Clause
  • Having Clause
  • Distinct Clause
  • Create and Insert
  • Deleting, Populating and Updating

SAS/SQL:

  • Introduction to SAS/SQL
  • Features & Uses
  • Terminology
  • Data Types, Key Words, & Operators
  • Functions, Predicate s & Functions
  • Formatting Output
  • Group By Clause, Order By Clause & Having Clause
  • Case Expression and Conditional Logic.
  • Creating, Populating & Deleting Tables
  • Alter Table Statement
  • Renaming a Table & Columns
  • Changing Column’s Length
  • Joins & Views

SAS/ACCESS:

  • Import & Export Procedure s
  • Importing data from Ms-Access & Ms- Excel
  • Importing data from Oracle database
  • DbLoad Procedure

SAS/GRAPH:

  • Gchart Procedure
  • Vertical, Horizonta l, Pie
  • Donut
  • Group,Subgroups
  • Gplot Procedure
  • Mutliple Plots & Overlay
  • Symbol Statement
  • Title and Footnote Statement's
  • Goptions

SAS/MACROS:

  • Macro Concepts
  • Macros And Macro Variables
  • Creating Macro Variables
  • Using Macro Variables
  • Creating Modular Code With Macros
  • Invoking A Macro
  • Adding Parameter s To Macros
  • Macros with Condition al Logic
  • Using Various Procedure s In Macros
  • Automatic Variables
  • Macro Functions
  • Including External Macros

Module – 4: SDTM STANDARDS

  • Importance of CDISC SDTM in Clinical SAS
  • SDTM Introduction & Standards.
  • Key SDTM concepts & Understanding the SDTM Standard
  • Application of SDTM Standards.
  • Annotation of CRF’s
  • SDTM Mapping Specification
  • Define.XML
  • >
  • Brief overview of the other CDISC concepts like CDASH, ODM.
  • Creation of SDTM annotated CRF.
  • A detailed review of SDTM concepts.
  • SDTM domain models and relationship tables.
  • A discussion of common implementation issues.
  • Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data.
  • Create case report tabulation (CRT) data set specifications per CDISC or sponsor specified requirements.
  • How to represent various types of collected data in the SDTM format.
  • Implementation of standard clinical data solution best practices from CRF design through data analysis and reporting.
  • COMPONENTS OF SAS
  • Create TLG,
  • SDTM data-sets
  • ADaM data-sets
  • CDISC Procedure for the CDISC SDTM 3.1 Format

Training Course Registration Form :

Please fill out the following form to sign up for one of our training course. This form will be submitted to our training coordinator who will contact you to confirm details of the offering before finalizing your registration.

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