Gratisol Labs Hyderabad www.gratisol.com : Pharmacovigilance/ Clinical Data Management Training

[gratisollabs]

Pharmacovigilance Training in Oracle Argus Safety Database with Internship

Organization at a Glance :
Gratisol Labs is a leading Clinical Research organization providing full range of Clinical Research, Clinical Data Management, CDISC SDTM, Pharmacovigilance & SAS training services to Healthcare Organizations globally.

The classes will be conducted at ‘GRATISOL LABS’, Road No.10, Banjara Hills, Hyderabad.

The focus of the lectures will be mainly on the following topics :
** History and over view of pharmacovigilance
** Introduction and responsibilities : USFDA, EMA and CDSCO
** Pharmacovigilance in India
** Clinical Development process
** Different phases of clinical Trials
** Adverse events and its types
** Drug Safety in clinical trials and post marketed drugs
** Different sources of Adverse events reporting
** Different types of AE reporting Forms
** Expedited reporting and its timelines
** Different departments working on Pharmacovigilance
** Roles and responsibilities of case receipt unit
** Roles and responsibilities of Triage unit
** Four factors for the reportable case
** Seriousness criteria of adverse event
** Expectedness or Listedness of adverse event
** Causality assessment of the adverse event
** Introduction to safety databases and different types
** Importance and procedure of duplicate check
** Case bookin or initiation
** Introduction to MedDRA and WHODD
** Narrative writing
** Case quality check, Medical review and its submission.
** The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
** PSUR and its submission timelines
Practical Training will be also provided on Safety Database on the following topics :
** Data Entry
** Case Processing
** MedDRA & WHODD coding
** SAE narrative writing.

Mode of training- Instructor Led Class room/ Online Training

Note : Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes.

Our candidates employed in Mahindra Satyam, GSK, Quanticate, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, AstraZeneca-UK and many more…

To reserve the seat immediately, send a DD of Rs.500/- in favour of Gratisol Labs payable at Hyderabad along with your resume by courier or registered post. You can also reserve the seat by doing cash payment at Gratisol Labs Premises.

Tenure : 2 month

Eligibility
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) / 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 Hospitals.

Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

For more information, please contact Gratisol Labs at training@gratisol.com

For More Details : Please Contact
Kunal Singh
Training Coordinator
Gratisol Labs
Plot No: 70, 3rd Floor,
Road No-10, Banjara Hills,
Landmark: Near Star Hospitals
Hyderabad AP – 500034
Contact No: 040-65741017,64615852, 8885198390, 9705790302
E: mail: training@gratisol.com
Website: www.gratisol.com

[gratisollabs]

Clinical Data Management Training in Oracle Clinical with Internship

Organization at a Glance :
Gratisol Labs is a leading Clinical Research organization providing full range of Clinical Research, Clinical Data Management, CDISC SDTM, Pharmacovigilance & SAS training services to Healthcare Organizations globally.

The classes will be conducted at ‘GRATISOL LABS’, Road No.10, Banjara Hills, Hyderabad.

The focus of the lectures will be mainly on the following topics :
** Introduction to Clinical Research & Clinical Data Management
** Fundamentals of Clinical Research &Roles in a CRO
** Clinical Data Management Process and Life cycle.
** ICH – GCP guidelines
** Protocol Designing
** CRF /e CRF Designing
** CRF Annotation
** SOP Preparation (Standard Operating Procedure)
** CDISC STANDARADS
** Preparation of essential documents in CDM process (Data Management Plan ,Database Structure Document, Edit Check Specification document, Study User Acceptance Test(UAT)
** Database Design
** Data Validation programming and standards
** Database testing
** Data entry
** Discrepancy Management
** DCF Management
** Electronic Data Capture and Remote Data Capture.
** Management of Medical Dictionaries(MeDDra, WhoDD)
** Query management(DCF management) Coding
** External data managing (e, g : Lab data, ECG, BMD etc.)
** Clean Patient Delivery
** Database Lock, Freeze.
** SAS data Extracts

Mode of training- Instructor Led Class room/ Online Training

Note : Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes.

Our candidates employed in Mahindra Satyam, GSK, Quanticate, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, AstraZeneca-UK and many more…

To reserve the seat immediately, send a DD of Rs.500/- in favour of Gratisol Labs payable at Hyderabad along with your resume by courier or registered post. You can also reserve the seat by doing cash payment at Gratisol Labs Premises.

Tenure : 2 month

Eligibility :
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) / 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.

Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.
For more information, please contact Gratisol Labs at training@gratisol.com

For More Details : Please Contact
Kunal Singh
Training Coordinator
Gratisol Labs
Plot No: 70, 3rd Floor,
Road No-10, Banjara Hills,
Landmark : Near Star Hospitals
Hyderabad AP – 500034
Contact No: 040-65741017,64615852, 8885198390, 9705790302
E: mail: training@gratisol.com
Website: www.gratisol.com

[Guest]

This is suman ,i am pursuing m.pharmacy(2nd year) . I have intrest on pharmacovigilance course and select as a carrer, but i having low english fluency so am i eligible for this course.

Which company's are hiring these trained students , are you giving assurance about the job after completion of the course.

please give me information about fee structure.

What is the future of this pharmacovigilance jobs & after completion of this course how much salary we can expected .

please give me answer to above question..

[Guest]

Hello,
My name is Krunal .i am a pharmacist and also have master Degree in pharmaceutical science from uk. I want to make my Career in clinical research field .can you tell me please which Course will be perfect to cover all entire knowledge with practical Training and tell me the duration and cost of the course please Thanks a lot