
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.
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.
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
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
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.
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!
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.