Qualified Pharmacovigilance Scientist Training Course

PHARMACOVIGILANCE SCIENTIST TRAINING COURSE

About Course

The “Qualified Pharmacovigilance Professional” training Programs is designed for graduates from medical, pharmacy or life science stream.The QVP training program covers all the technical aspects of pharmacovigilance job and provide ICSR case processing training with live pharmacovigilance projects. The Program is of 12 weeks delivered by industry professional who have immersed experienced in the field.THE QVP program is perfect blend of Theoretical and practical training which helps you excel in the job.

Course Learning Outcome

Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance
Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments, such as the QPPV (Qualified Person for Pharmacovigilance), Drug Safety Physician, Drug Safety Data Analyst, Drug Safety Associate, Drug Safety Data Entry Associate, Drug Safety Triage Officer, Drug Safety Auditor, Drug Safety Regulatory Associate, and others
Detailed training in MedDRA coding and medical narrative writing for SAE reports.
Expertise in regulatory report writing like ISS/ISE, ICSR, PSUR, PBRER, SUSAR, aggregate reports and others as required for various regulatory compliance.

TRAINING MODULES

BASIC & REGULATORY ASPECTS OF PHARMACOVIGILANCE

Introduction & History of Pharmacovigilance
Pharmacovigilance complete Process
Pharmacovigilance Terminologies
Introduction & origin of Pharmacovigilance Guidelines
Regulatory authorities – Worldwide
International Conference on Harmonization (ICH)
Guideline on good Pharmacovigilance practices (GVP)
FDA 21 CFR Part 11

SOURCES & PROCESSING OF ICSRS

Rationale for Pharmacovigilance Monitoring
Safety in the Lifecycle of Products
PRE-MARKETING SAFETY ASSESSMENT
POST-MARKETING SURVEILLANCE
POST-MARKETING SURVEILLANCE METHODS
ICSR PROCESSING
- Date of receipt
- Case validity
- Seriousness assessment
- Expectedness determination
- Case Follow-up Approaches
- Causality assessment
- Narrative writing
- Special Case Scenarios
- Case Nullification
- Record retention
- ICH E2B ICSR Transmission – Data Elements

ICSRs PROCESSING WITH SAFETY DATABASE & MEDDRA CODING

Introduction to safety databases
Case Processing in E2B Compliance Safety Database
MedDRA v20.0
- Scope, Introduction, Definition, Maintenance, Rationale
- MedDRA Applications
- Structure of MedDRA
- MedDRA Conventions
- Coding Guidelines
- MedDRA Important Medical Events (IME)
- MedDRA for Aggregate Data Output
- Change Request Information
- The MSSO Change Request Process
- MedDRA Version updates

REGULATORY REPORTING IN PHARMACOVIGILANCE

Expedited reporting
Aggregate Reporting
- PSUR
- PBRERs
- ADCO
- DSURs
Signal Detection & Assessments

Career Opportunities

• Fresher Level job in Pharmacovigilance is DSA (Drug Safety Associate). A Drug safety Associate is mainly involved in case creation, checking for MSI (Minimum safety information - a patient, a reporter, a suspect drug and a adverse event), reconciliation and follow up process, data entry of all information available in the document and medical coding

• 3 Years of experience builds more skill sets as (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc) which can bag him a position as DSS (Drug Safety Scientist).

• With a Certification in Pharmacovigilance and an overall of 5+ Years experience, candidates can become a Team lead or Team manager based on the company.