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Gratisol labs are a software development and training organization. we specialize in developing various job oriented training programs primarily focusing towards clinical science, health care and sas reporting practices. We help professionals and students to opt for the best career pathway per their education. Gratisol labs staff and professional advisors bring their scientific, regulatory and informative management experience to deliver timely, accurate, cost-effective programs, which will help its users to apply the learning direct into business.
Learning’s for job
Technical learning's:
Extensive knowledge of drug safety and drug development process and procedures
In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines
Extensive knowledge of us and ich safety reporting regulations and guidelines.
good understanding of in safety reports, 21 cfr part 11 and hippa guidelines.
A source in accordance with fda and ich guidelines
Working knowledge pertaining to MedDRA and who drug dictionaries.
proficient in data entry and excellent knowledge of argus safety database.
hands on experience:
1. medical record extraction
extracted relevant medical data from the medical information provided and entered data into company case template of the case.
2. triage
reviewed adverse event cases and performed triage
reviewed cases for minimum criteria, determine clock start date of case and due date for case and determine type of case.
3. case processing
reviewed SAE report forms.
created the case in the safety data base (safety database screens developed in house)
performed data entry into given drug safety database screens and written narratives
4. MEDDRA coding
applied knowledge on MEDDRA coding for issuing queries for all discrepancies found while coding on situational case scenarios on following concepts
investigator brochure/labeling/coding information for coding
coding convention
regulatory status-msso
ambiguous laboratory data
missed concepts for MEDDRA coding
hierarchy in MEDRA Coding and grading of AE
5. case narratives
generated well written, concise and accurate narratives for both serious and non-serious cases.
6. drug safety database and software
working knowledge pertaining to the functionality and features of drug safety database (oracle argus).
7. SAE reconciliation
reviewed sop for reconciliation of the serious adverse event database and sop for procedure description for SAE reconciliation
reconciled serious adverse events reported during the conduct of a clinical research trial in the clinical database with serious adverse events (SAES) recorded in the safety database.
performed reconciliation to assure that serious events are accurately captured, and interpreted.
Eligibility:
bachelor's, master’s, or phd, M.B.B.S/ 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 hospital.
internship with stipend:
the internship conducted at gratisol labs provides internship with stipend .relocation is required to participate in internship program. the student enrolled in this training will be exposed to various real-time exercises exercise scenarios perform at job in part to real-time and industry standards. at the end of the internship program, the student will have to write a final objective exam for getting certified & placements.
upon completion of the training cum internship program each intern will be provided with a course completion certificate and post assistance training program. this program includes job preparation support kit (sample resumes, narrative preparation process and mock interviews with experienced domain expert professionals).
relocation is required for internship JOB PROGRAMME.
career pathways:
drug safety associate, drug safety scientist case processor, triage specialist, narrative writer, medical record extractor, senior drug safety associate, medical reviewer.
for more information, please contact gratisol labs at gratisollabs@gmail.com.
venue for demo:
Gratisol Labs
KVR Enclave, 2nd Floor, Gurudwara Lane
Beside Satyam Theatre, Above ICICI Bank & Bata Showroom
Ameerpet, Hyderabad – 500016
contact details:
9705790302.
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