Model Curriculum · (PSMF), Risk Management Planning(RMP), Periodic Safety Update Reports (PSURs)...

PHARMACOVIGILANCE ASSOCIATE 1

Model Curriculum

Pharmacovigilance Associate

SECTOR: SUB-SECTOR:

OCCUPATION: REF ID:

NSQF LEVEL:

LIFE SCIENCES PHARMACEUTICAL, BIOPHARMACEUTICAL, CONTRACT RESEACRCH PHARMACOVIGILANCE LFS/Q0702, V1.0 4


Complying to National Occupational Standards of Job Role/ Qualification Pack: ‘Pharmacovigilance Associate’ QP No. ‘LFS/ Q0702, V1.0

NSQF Level 4’

Date of Issuance: Aug 16th , 2019

Valid up to Aug 01st

, 2023

* Valid up to the next review date of the Qualification Pack

Authorized Signatory (Life Sciences Sector Skill Development Council)


TABLE OF CONTENTS

1. Curriculum 01

2. Trainer Prerequisites 09

3. Annexure: Assessment Criteria 10


Pharmacovigilance Associate CURRICULUM / SYLLABUS

This program is aimed at training candidates for the job of a “Pharmacovigilance Associate”, in the “Life Sciences” Sector/Industry and aims at building the following key competencies amongst the learner.

Program Name Pharmacovigilance Associate

Qualification Pack Name and Reference ID. ID

Pharmacovigilance Associate LFS/Q0702, V1.0

Version No. 1.0 Version Update Date 16-08-2019

Pre-requisites to Training Graduate in Life Sciences subjects/ Pharma / Biotechnology/ Nursing

Training Outcomes After completing this program, participants will be able to: • Explain the salient aspects of the life sciences industry and its

pertinent regulations in order to demonstrate performance that is in line with industry standards.

• Perform the collection, processing and, assessment of Individual Case Study Reports (ICSRs).

• Perform various pharmacovigilance activities by using software and drug safety databases.

• Ensure regulatory compliance by compiling, identifying and improving issues in regulatory compliance of ICSRs.

• Synchronize work with medical coder/ reviewer, safety physicians, supervisors and, cross-functional teams and auditors to achieve work goals.


This course encompasses 4 out of 4 Compulsory NOS (National Occupational Standards) of “Pharmacovigilance Associate” Qualification Pack issued by “Life Sciences Sector Skill Development Council”.

Sr. No.

Module Key Learning Outcomes Equipment Required

1 Orientation to Life Sciences industry and its regulatory framework Theory Duration (hh:mm) 08:00 Practical Duration (hh:mm) 00:00 Corresponding NOS Code Bridge Module

• Explain the Life Sciences industry • Summarize regulatory authorities rules and

regulations for pharmacovigilance • Recall detailed norms pertaining to Good

Documentation Practice (GDP) and Good Clinical Practice (GCP)

• Explain the organizational structure and employment benefits in the Life Sciences Industry

• Outline the role of a Pharmacovigilance (PV) Associate and practice the required skills (as per Qualification Pack)

• Overview pharmaceutical industry, it's functioning and role of various departments in operation of pharmacovigilance activities

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, and duster

2 Basics of Pharmacovigilance Theory Duration (hh:mm) 16:00 Practical Duration (hh:mm) 24:00 Corresponding NOS Code LFS/N0701

• Explain human anatomy and physiology • Describe the basics of pharmaceutical

sciences including formulations, sources of APIs, drug development, pharmacodynamics, and pharmacokinetics

• Explain the fundamental study of clinical research including basics of Bioavailability/Bioequivalence studies, clinical trials and types of clinical trials.

• Describe the process to perform the activities related to Post Marketing Surveillance (PMS), Pharmacovigilance System Master File (PSMF), Risk Management Planning (RMP), Periodic Safety Update Reports (PSURs) and Signal Management.

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk


Management Plan (RMP) and sample Patient Information Leaflet

3 Global/Local Medical Literature Surveillance Theory Duration (hh:mm) 12:00 Practical Duration (hh:mm) 18:00 Corresponding NOS Code LFS/N0701

• Explain literature databases like PubMed, Embase, etc.

• Describe the importance of local literature search

• Explain the methods and signal search strategies

• Search strings using drug safety databases • Carry out screening, review and assessment

of search records • Identify abstracts and full-text articles in the

published medical literature databases

Computer system, LCD projector, white screen/ LCD monitor, pointer, whiteboard, marker, duster, High-speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

4 Safety Databases and Other Tools Theory Duration (hh:mm) 20:00 Practical Duration (hh:mm) 30:00 Corresponding NOS Code LFS/N0702

• Explain detailed safety process providing automated global case processing, periodic reporting, E2B intake and submission, comprehensive reporting, detailed analytics, and safety operations from a single system

• Identify relevant software tools to enable compliance, quality and, efficiency in safety operations

• Explain Drug Safety Databases like Argus, ArisGlobal, Safety Easy (AB Cube) and EudraVigilance

• Demonstrate the use of softwares like VigiFlow and VigiBase for ADR reporting

• Identify essential components of a typical safety database (various sections/tabs)

• Use MedDRA software tools

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance


• Recall national and other international adverse reporting forms and aggregate report templates

• Demonstrate the procedure for the entry, classification, coding and, assessment of adverse event reports, in accordance with international standards and guidelines by using appropriate software tool

• Collect and process ICSR data • Perform manual data entry from ADR paper

forms by using WHO Drug and MedDRA • Perform post-marketing surveillance to store

the safety profile and adverse event reports of the drug

• Perform coding of relevant medical terminologies using MedDRA and WHO-drug dictionary

• Facilitate compliance with domestic and global safety reporting obligations for drugs, vaccines, biologics, devices and combination products

Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

5 Software Validation and Artificial Intelligence (AI) in Pharmacovigilance Theory Duration (hh:mm) 24:00 Practical Duration (hh:mm) 36:00 Corresponding NOS Code LFS/N0702

• Describe the application of software validations

• Identify types of software validation • Identify AI future software validation tools (IQ,

OQ, and PQ) before using the software tool or databases

• Describe the fundamental basics of artificial intelligence (AI)

• Explain the relevance of artificial intelligence (AI) in the field of pharmacovigilance

• Explain the applications of artificial intelligence (AI) for the role of pharmacovigilance associate

• Use artificial intelligence (AI) in ICSR processing

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms,


Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

6 Individual Case Safety Reports (ICSRs) Writing Theory Duration (hh:mm) 16:00 Practical Duration (hh:mm) 24:00 Corresponding NOS Code LFS/N0701

• Describe general principles in relation to the collection, processing and, reporting of all Adverse Events (AEs)/ Adverse Drug Reactions (ADRs) associated with pharmaceutical products for human use

• Differentiate between AEs and ADRs • Identify the seriousness criteria of the AEs and

ADRs • Explain the causality assessment • Explain the types of reports in the

pharmacovigilance process • Explain ICSR reports including expedited

(serious reports, at risk reports), non-expedited reports and aggregate report

• Explain the stages of ICSR processing which includes triage, data entry, quality check and, medical review

• Perform data entry for ICSRs into safety databases

• Take part in submission of expedited reports for the pharmacovigilance

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

7 Pharmacovigilance Quality Management System (PQMS) Theory Duration (hh:mm) 08:00 Practical Duration (hh:mm)

• Describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System (PQMS)

• Explain how the elements of the Pharmacovigilance and a Quality Management System fit together to achieve regulatory compliance

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug


16:00 Corresponding NOS Code LFS/N0703

• Identify the structures and processes of a quality system and a pharmacovigilance system

• Develop Pharmacovigilance System Master File (PSMF)

Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

8 Regulatory Compliance in Pharmacovigilance Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 16:00 Corresponding NOS Code LFS/N0703

• Identify the responsibilities of key pharmacovigilance stakeholders such as Regulatory Authority, Market Authorization Holders (MAHs), Public stakeholders i.e. Physician/Patient, Qualified Person Responsible for Pharmacovigilance (QPPV), PV Departments

• Review the timely submission of ICSRs, PSUR, RMP, signal reports and aggregate reports while ensuring the accuracy of reports on a regular basis

• Participate in regulatory inspection/ internal and client audit Identify the issues hindering the regulatory compliance

• Prepare a response to non-compliance reports by initiating an investigation for the deviations

• Identify the cause of the deviation • Record documentation for each corrective and

preventive actions (CAPA) taken to ensure compliance

• Improve regulatory compliance

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of


WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

9 Coordination with Medical Coder/ Reviewer, Safety Physicians, Supervisors, and Cross-Functional teams and auditors Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 12:00 Corresponding NOS Code LFS/N0704

• Follow the escalation matrix for any internal communication

• Explain the rules of data integrity as per Good Clinical Practices and Good Manufacturing Practices

• Exhibit the core and professional skills like communication, problem-solving, planning and organizing, critical thinking during the coordination related activities

• Coordinate with the team members during the quality check for the cases, and inform intervention-requiring issues to supervisor

• Route cases to the medical reviewer for the next workflow

• Support Patient Support Program Associate/ Data Assistant in mining the spontaneous reports submitted to the national surveillance systems

• Participate in the departmental audits • Maintain data integrity while responding to

auditors

Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet

Total Duration Theory Duration 124:00

Unique Equipment Required: Computer system, LCD projector and screen/ LCD monitor pointer, whiteboard, marker, duster, Indian Pharmacopeia 2018, 8th Edition/ IP 2018, Pharmacovigilance Program of India Guidelines, Indian Drug Formulary, draft


Grand Total Course Duration: 300 Hours 00 Minutes (recommend additional 1152 Hours OJT/ Apprenticeship)

(This syllabus/ curriculum has been approved by Life Sciences Sector Skill Development Council.)

Practical Duration 176:00 OJT Duration 00:00

sample copy of Pharmacovigilance System Master File (PSMF), Indian Good Pharmacovigilance Practices and Good Clinical Practices(GCP) e-subscription, High speed black and white printer, High speed internet connection, excel based replica of drug safety databases, Excel-based replica of MedDRA Dictionary, Excel-based replica of WHO Drug Dictionary, Sample SOPs, sample Periodic Safety Update Reports (PSURs), sample Adverse Events (AE) reporting forms, Sample Individual Case Safety Report (ICSR), sample Risk Management Plan (RMP) and sample Patient Information Leaflet


Trainer Prerequisites for Job role: “Pharmacovigilance Associate” mapped to Qualification Pack: “LFS/Q0702, V1.0”

Sr. No.

Area Details

1 Job Description To deliver accredited training service, mapping to the curriculum detailed above, in accordance with the Qualification Pack “LFS/Q0702, V1.0”.

2 Personal Attributes Aptitude for conducting training, and pre/ post work to ensure competent, employable candidates at the end of the training. Strong communication skills, interpersonal skills, ability to work as part of a team; a passion for quality and for developing others; well-organized and focused, eager to learn and keep oneself updated with the latest in the mentioned field.

3 Minimum Educational Qualifications

B. Pharma

4a Domain Certification Certified for Job Role: “Pharmacovigilance Associate” mapped to QP: “LFS/Q0702, V1.0”. Minimum accepted score is 80% as per LSSSDC guidelines.

4b Platform Certification Recommended that the Trainer is certified for the Job Role: “Trainer”, mapped to the Qualification Pack: “MEP/Q2601”. The minimum accepted score is 80% as per LSSSDC guidelines.

5 Experience Preferably Minimum Eight (8) years’ experience in life sciences with Pharmacovigilance occupation for non-trained and non-qualified talent with B. Pharma degree educational qualification Or Preferably Minimum Six (6) years’ experience in life sciences with Pharmacovigilance occupation for non-trained and non-qualified talent with M. Pharma educational qualification Or Preferably Minimum Four (4) years’ experience in life sciences Pharmacovigilance occupation for non-trained and non-qualified talent with MBBS educational qualification


Annexure: Assessment Criteria

Please refer to the QP PDF for the Assessment Criteria.

Model Curriculum · (PSMF), Risk Management Planning(RMP), Periodic Safety Update Reports (PSURs)...

Documents

Transcript of Model Curriculum · (PSMF), Risk Management Planning(RMP), Periodic Safety Update Reports (PSURs)...