gartisol
education
500073 hyderabd
India
Gratisol Labs is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates.
The services offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Application Training in Clinical Data Management (Oracle Clinical, Oracle Inform/Central Designer), Pharmacovigilance (Oracle Argus Safety Database, Oracle AERS), CDISC SDTM & SAS to aspirants of Clinical Research Industry. We successfully help some of the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals.
The Pharmaceutical & Clinical Research Industry, worldwide is facing a huge shortage of trained manpower resources. With a View to fill this gap between the demand & supply of trained manpower and to help Pharmaceutical & Clinical Research industry to move on the fast track Gratisol Labs offers cutting-edge packaged and customized corporate training programs. In addition, Gratisol Labs has developed a tailored training division. Gratisol Academy of Clinical Research to provide Training, Internships, & Educational programmes that are designed to develop careers for clinical research professionals in Clinical Data Management, Pharmacovigilance & SAS.
We have the global capabilities and a flexible approach to meet our clients needs. Our operational excellence brings quality, efficiency and effectiveness to operational performance. The services offered fall into the broad categories of temporary staffing, permanent placement, outsourcing, consulting and outplacement. We successfully help some of the top scientific, clinical, biotechnology and pharmaceutical organizations from around the world to recruit high caliber experienced professionals.
Through our vast nationwide network and talent sourcing model we are able to rapidly respond to our clients with excellent results and personalized customer service, making us one of the most innovative and reliable healthcare staffing and search firms.
Gratisol Labs also provides Site Management Services, Clinical Data Management, Pharmacovigilance, Medical Writing, Biostatistical Analysis, SAS Programming & IT Support Services to Pharmaceutical, Biotechnology and Medical Device Organizations globally.
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
Gratisol Labs Advantages:
» Oracle Argus Safety Database - Latest Production Version 7.0
» 4 months internship available after training
» Own CRO live projects
» Highest Placement record across all training institutes
» Industry SOPs based training
» Trainers with minimum 5 years experience
» 24 hours access to application lab
Course Timings
10:00-11:00 Am
Trainer Information
Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes
Additional Information
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
Contact Information
Gratisol Labs,
Vasav MPM,8th floor,905,Ameerpet,Opposite South India Shopping mall
Ameerpet,Hyderabad
Call : 9705790302
Website: https://gratisol.com/
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