Online/Class Room Training-Advanced PG Diploma in Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training - Project Experience Certification & Placement Assistance BioMed Informatics Medwin Hospitals (Established in the year of 2000) ? Before joining in BioMed Informatics Medwin Hospitals, You are welcome to check the appointment letters of our previous students issued by MNCs like Novartis, Quintiles, Accenture, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge and so on. ? We never make any phone calls to insist the candidates to join here by making empty promises. After completion of PG Diploma: You can learn Argus Safety software by which you are eligible to apply in the domains of Pharmacovigilance & Argus Safety in Cognizant, Novartis, Quintiles, TCS, Parexel, MakroCare, Synowledge, HCL, Tech Mahindra, Wipro, Accenture and many more…. You are eligible for Pharmacovigilance Jobs You are eligible for Argus safety Jobs in IT Companies You are also eligible for any healthcare Jobs because of the availability of the patient data in Medwin Hospitals Features: • Certificate will be provided after successful completion of the course • Project experience certificate will also be provided • Placement Support will be provided • Resume preparation tips / Interview guidance • Printed material will be provided • Practical Hands-on training on Database • Direct access will be provided to Argus Safety Database • We also offer Instructor-Led Online Trainings BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering trainings since the year of 2000 that are helpful for Pharmacy/Life Sciences students to enter into IT Companies and Pharma, Biotech, CRO industries. Our candidates employed in Novartis, Quintiles, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more… Interested candidates are kindly requested to fill Enquiry Form in the website www.biomedlifesciences.com for further information. Please note that we also provide separate hostel facility assistance for ladies as well as gents. Contact: G.V.L.P.Subba Rao Mobile: 9989684450 BioMed Informatics (Established in the year of 2000) Medwin Hospitals B Block First Floor, Nampally, Hyderabad – 500 001 Phone: 040 – 40209750 Website: www.biomedlifesciences.com

Topics Covered

Pharmacovigilance • Clinical Development process • Different phases of Clinical Trials • History and overview of Pharmacovigilance • Introduction and responsibilities of USFDA, EMA and CDSCO • Pharmacovigilance in India • 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 • Importance and procedure of duplicate check • Data Entry • Case booking or initiation • Case processing • MedDRA and WHODD coding • SAE narrative writing • Case quality check, Medical review and its submission • PSUR and its submission timelines Oracle Argus Safety Database Argus Console: • PV Overview • PV Business process • Introduction to Oracle Argus Safety Database • Family, Product and License creation • Study creation • Sites, users and Groups creation • Workflow Configuration • Expedited Report Configuration • Case priority Configuration • Case Numbering • Field Validation • Code list Configuration • LAM (Local Affiliate Module) Configuration Argus Safety: • Different icons used during the case processing and their purpose. • Different tabs used in case processing • Minimum requirements for a case bookin • Case Bookin and Data entry • Case Processing • Case Routing Based on workflow • Case Quality check, Medical review • Duplicate case check or verification • Report Generation for Regulatory Submission • Expedited Reports and Aggregate Reports • Case Bookin in LAM and Routing to Central Safety database • MedDRA coding and WHO DD coding • Narrative Writing • Different Case Studies

Who should attend

Eligibility : Pharmacy: B.Pharmacy,M.Pharmacy, Pharm D Life Science: M.Sc life Sciences (All Groups or Braches) Health Science: MBBS,BDS,BHMS,BPT,All medicine professionals

Pre-requisites

Pharmacy/ Life Sciences

What you need to bring

Pen and Note Book

Key Takeaways

Pharmacovigilance argus safety database