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Pharmacovigilance

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Objectives
Eligibility
Course Outline
FAQ'S
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A pharmacovigilance professional is typically involved in collecting, monitoring, processing and reporting adverse event reports. They follow-up with reporters to gain more details on case reports, and also provide information of product safety to patients and health care professionals. They act as the in-house safety resource in connection with safety issues.

The Pharmacovigilance training & internship provided in Clinnovo Research Labs equips the students to gain expertise in order to deliver efficient functioning in the organization that they are a part of. Clinnovo puts more emphasis on ICSR, PBRER, ADR, MedDRA and case narrative during the training on pharmacovigilance. It develops in students the potential to identify the nature of a suspected adverse eventcase, identify obstacles and work to resolve it in the predetermined timeline. It also develops analytical expertise in understanding the case processing flow of reported AEs and the latest update of the case with current available information.

The training programs provided by Clinnovo are suitable for Life science Graduates, Doctors, Medical Professionals, Pharmacists etc.

Anyone of the following minimum qualification is mandatory to eligible.

  • B.Sc / M.Sc in Biotechnology

  • B.Sc / M.Sc in Microbiology

  • B.Sc / M.Sc in Genetics

  • B.Sc / M.Sc in Biochemistry

  • B.Sc / M.Sc in Life Sciences

  • M.B.B.S / B.D.S / B.A.M.S / B.H.M.S

  • B.Pharmacy / M.Pharmacy

  • Pharm.D

  • Graduates or Post Graduates in Nursing

  • B.E (BT) / B.Tech (BT)

  • Ph.D in Life Sciences / Biomedical Science

  • Introduction to Pharmacovigilance

  • Clinical Development process

  • Responsibilities :USFDA, CDSCO

  • Pharmacovigilance in India

  • Drug Safety in clinical trials and post marketed drugs

  • Different sources of Adverse events reporting

  • Different types of AE reporting Forms

  • Adverse events and its types

  • Expedited reporting and its timelines

  • Four minimum information for a reportable case

  • Seriousness criteria of adverse event

  • Expectedness ( Listedness) of adverse event

  • Causality assessment of the adverse event

  • Case Narrative writing

  • Case processing

  • Periodic Safety Update Report (PSUR) and its submission timelines

  • Development Safety Update Report (DSUR)

  • Roles & Responsibilities in a CROs & Sponsor in Pharmacovigilance.

  • Medical Dictionary for Drug Regulatory Activities - MedDRA

  • Overview of Oracle Argus

During the training period thefollowing modules will be covered as a part of Student career Improvement Program.

  • Communication and Soft skill development

  • Just A Minute Sessions

  • Seminars

  • Case studies

  • Mock interviews

  • Guest lectures

  • Student improvement program

  • Professional career building

  • Organizing Resume

  • Knowledge Sharing on new techniques

For more information please contact at 9912868928
Can I attend a demo session before enrollment?
Yes
What Features do you provide?

Class Room & Online Live sessions
Ongoing projects
Expert faculty 
Mock Interviews 
Aptitude Test 
Guest Lectures 
Lab facilities
Resume preparation
Placement assistance
Software installation
Clarification Q&A sessions

Do I receive a certificate for training ?

Once you are successfully through the course you will be awarded with Clinnovo Training certificate.





Reviews

Average
4.6
(5 Ratings)

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Jnaneswari

Senior Researcher. GDRC

I have joined in Clinnovo Research Labs, Hitech City, Hyderabad for SAS and classroom Pharmacovigilance training with internship, Job Assistance. Had an awesome experience with the tutors for improving my skillset by giving Weekly assignments and timely exams. Highly Recommended. Thank you.

Sulthan

Safety Associate MICC Department

Clinnovo provided an excellent and effective classroom training in Pharmacovigilance. The courses were well designed and well taught out with the right level of challenge for new comers like me. I have found this courses very beneficial and feel the techniques learned will enable me to secure a good job in the future.

Punsiba Sapam Singh

Safety Associate

I have joined in Clinnovo Research Labs, Hitech City, Hyderabad and here i have the Online Pharmacovigilance training with intership and Job Assistance. The subject was in depth. Faculties with industry experience has taken the sessions. They are very supportive and helpful. Thanks Clinnovo!



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