Job Description
Dear Candidate,
We are Hiring Freshers for Clinical Research & Pharmacovigilance Freshers Openings .
Clinical Research Assocaite should be aware of
Aware of ICH GCP Guidleines
Clinical Trail Process,ICMR Guidelines, Schedule Y
Regulatiry bodies in CR
Latest Amendments in Schedule Y
The Drug Safety Associate will be responsible for processing and oversight of (AE) adverse event/drug experience reports (serious and non-serious) and other safety-related data for Incite marketed products and clinical trials. The position will be responsible for the case management life cycle from receipt through case completion.
Completion of the case management life cycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up, and submissions.
The Drug Safety Associate will ensure the rapid and accurate data entry of AE reports into the safety database,
File, track, and prepare SAEs narratives and reports, track AEs during a study.
Receive, process, complete data entry and follow-up on AEs/SAEs reports (spontaneous, literature, solicited, domestic and foreign origin) utilizing the PV Works database, in accordance with company SOPs.
Forward SAE Reports which have been received for Book-in and Data entry into Argus Database
Complete processing of the SAE in Argus Safety or equivalent database, ensuring the accuracy of event coding, event assessment, medical history, and laboratory data as well as composing the summary narrative
Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to ICSR case processing and workflow management
Drug Specialist will also include processing of ICSRs, and ensuring SUSAR submission compliance.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Required Candidate profile
Any Medical, Paramedical, Pharmacy and Life Science - Graduates and Post Graduates
Nursing, B.Pharm, M.Pharm, PhD
MBBS, MD, MS, DNB, DM
BDS, MDS, BAMS, BHMS, BUMS
BPT, MPT, B.Tech, B.sc, M.sc, PhD
Biotechnology / Microbiology/ Biochemistry /Zoology/ Anatomy/Physiology/ Bioinformatics/ Health Education/Lab Technician/ Chemistry/ Biomedical etc.
Working Professionals
4th/6th year B.Pharm/Pharma D students and 2nd year M.Pharm/M. Sc Students are also eligible
And all Passed out 2019,2018 and 2017 Pharmacy / Life Science / Medicine professionals who are looking to shift career to Clinical Research Industry from CALL CENTER JOBS or Tech Support Jobs. Insurance Claims Analyst Jobs. Sales Jobs. Research Associate Jobs or Secondary research Jobs. Conference publishing jobs. Night Shift Jobs like medical coding. can also apply
Apply Now: Send me your Resume on Whatsapp 8375822*** HR KaranRole Intern
Industry Type Pharma, Biotech, Clinical Research
Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Employment Type Full Time, Permanent
Role Category Medical Professional
Employement Category:
Employement Type: Freshers
Industry: Hospitals
Functional Area: Health Care
Role Category: Fresher
Role/Responsibilies: Clinical Research Pharmacovigilance Freshers Apply Now
Contact Details:
Company: Nanu India Recruitment
Location(s): Delhi, NCR
Keyskills:
Bp
Biotechnology
pharmaceutical
Microbiology
m.pharmacy
Nursing
b.pharmacy
Call Center
Lab
Healthcare
Medical Coding
Fresher
Voice Process
pharm d
Genetics
Medical Representative
Mr