Drug Safety Associate - Industry Certified Program - Chandigarh

Drug Safety Associate - Industry Certified Program
•Do you want to get enter into fastest growing industry of Pharmacovigilance where you can get a good salary package and growth?
•Then be a certified Drug Safety Associate and start working in companies like Quantum, Quintiles, Accenture, Novartis, Paraxel, Kindle, Apcer etc.
The Drug Safety Associate training program at Academy of Clinical Intelligence (an industry authorised training centre) provides an opportunity to get trained for the job that will give you the competitive edge to succeed in the fastest growing industry of Pharmacovigilance. You will be trained for drug safety associate positions through in-depth knowledge and practical exposure.
This training will provide learners with the regulatory references, processes, best practices, analysis and investigation techniques. Practical training includes a hand on case processing on Oracle Argus Safety Database 7.0 including Data Entry, Case Processing, MedDRA & WHODD coding and SAE narrative writing.
TRAINING OUTCOMES:
After the training, you will be able to:
•Demonstrate knowledge of safety concepts, per ICH, USFDA, GVP guidelines per drug safety reporting requirements
•Evaluate adverse event reports including triage, assessment of validity, seriousness and expectedness, causality etc.
•Perform Duplicacy and Initial case entries, identifies and initiates requests for case follow up for clinical trials and post marketing adverse events
•Perform full case entry into Argus Safety 7.0.2 suit including MedDRA & WHODD coding and SAE narrative writing
•Ensures departmental workflow processes and timelines are followed
POTENTIAL JOB TITLES
•Drug Safety Associate
•Medical Safety Officer
•Surveillance Safety Officer
•Pharmacovigilance Case Associate/Specialist
PROGRAM DETAILS:
Total Length: 2 Months
Learning Level: Industry Standards
Eligibility: 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./MA (Statistics) and all professionals working with pharmaceutical companies, CROs and hospitals
OTHER PROGRAMS OFFERED:
•Clinical Data Analysts - Industry Certified Program (2 months) with Oracle Clinical 4.6 & Oracle Inform Central Designer.
•Clinical Research Associate/Coordinator - Industry Certified Program (2 months)
•Clinical SAS Programmer - Industry Certified Program (2 months)
•Medical Writer - Industry Certified Program (2 months)