Diploma in Pharmacovigilance – To learn the applicable international guidelines, reporting procedures, reporting forms, reports etc.
Pharmacovigilance is the identification, evaluation, awareness and prevention of adverse reactions, especially the long-term and short-term side effects of therapeutic drugs, devices and biologics.
There are common guidelines and principles that regulate the globalization of the health and pharmaceutical industries. Therefore, the implementation of a global systemic structure for pharmacovigilance requires a large number of trained professionals in this area.
The online course Professional Certification in Pharmacovigilance (PCPhV) allows learners to take an in-depth look at the relevant global standards, AE reporting methods and procedures, findings and evaluations, etc.
For more details, you can see the Curriculum Tab. This course would provide you with the necessary knowledge and thus enable you to excel on your career as a Drug Safety Associate or Pharmacovigilance Associate with Pharmaceuticals / Biotech Cos., Research Cos., IT firms, CROs, Hospitals, PV Centers, SMOs, KPOs, etc.
Module 1: Introduction to Pharmacovigilance
Module 2: Global Perspective of Pharmacovigilance and Adverse Drug Reaction (ADR) Reporting
Module 3: Guidelines and Standards Governing Pharmacovigilance
Module 4: Global AE Reporting System and Reporting Forms
Module 5: Individual Case Safety Reports (ICSRs)
Module 6: Public Safety Update Reports (PSURs)
Module 7: Signal Detection
Module 8: Medical Dictionary for Drug Regulatory Activities (MedDRA)
Module 9: Expedited Reporting & Requirements
Module 10: Pharmacovigilance Inspections
Assessment through Online Exam
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Length: 4 weeks
Timings: Self Paced
Effort: 55 hrs. approx
Skill Level: All