 Organization at a Glance:
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, Training in Clinical Data Management, Pharmacovigilance,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 Global 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
Visit www.gratisol.com for more information.
Gratisol Labs Advantages:
• 2 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
Program Highlights:
• Course material including detailed information about the entire work flow of Drug Safety Associate.
• Power Point presentations providing an overview of the topics discussed.
• “WE PROVIDE REAL TIME EXPERIENCE ON GLOBAL DRUG SAFETY SOFTWARE.”
Our team of experiences Drug Safety Specialists also provides the following upon successful completion of the training:
• Resume Preparation.
• Interview preparation with real time questions and answers.
• Mock interview sessions.
• Communication skills and personality development sessions.
• Placement Assistance
For More Details: Please Contact
Kunal Singh
Training Coordinator
Gratisol Labs
Plot No: 315, Vikas Surya Plaza,
Rohini Sector-3, Mangalam Place
New Delhi - 110085
India
Contact No: 011- 42484713, +91 8595372408 |
