Pharmacovigilance Introductory SlideDeck

Slide deck for Pharmacovigilance students/beginners, Healthcare professionals, pharmacists, nurses. Education purposes, interview preparation and career guidance

1. Pharmacovigilance - Job Opportunities Challenges & the Way Forward

2. Agenda Pharmacovigilance (PV) India initiatives and success so far PV Market and Job opportunities Potential barriers and how to overcome these Closing Remarks

3. PV: What, How, Why, Who?

4. Pharmacovigilance (PV) The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine/device related problem The scope of PV to improve patients’ safety includes detection and reporting of ADRs, medication errors, counterfeit and substandard medicines , lack of efficacy of medicines, misuse and/or abuse of medicines, and drug–drug interactions

5. Evolution of PV 5 *ASA: acetylsalicylic acid; **WHO: World Health Organization; ***EMA: European Medicines Agency

6. PV in Clinical Trials & Post Market Surveillance PV begins with Clinical Trials (CTs) that provide data on the benefits and risks continuous monitoring & evaluation of all adverse events during drug development assessing the safety of participants and evaluating the risk and benefit to determine whether the benefits outweigh the risks obtaining approval to market the new drug based on safety data safety data collected during CTs is not exhaustive – Post Marketing Surveillance

7. Outcomes Reference Safety Information (RSI) Package Insert/Leaflet Contraindications Warnings on labeling (Safety) data collection in special situations Study termination / Product recalls (Safety/Benefit)

8. Need of PV Ever-expanding Safety/Risk Data

9. Need of PV In USA, cost per ADR in ICU & non-ICU wards is estimated at $19,685 & $ 13,994, respectively Estimated cost of drug-related morbidity and mortality is $136 billion annually, higher than the total cost of cardiovascular or diabetic care in the US (Source: FDA) Costly Affair Promoting rational use of medicines and adherence Identifying counterfeit and substandard medicines (ensuring Quality) Ensuring public confidence Other Key points

10. Key Stakeholders 10 Regulatory Authorities National Competent Authorities (NCA) / Health Authorities (HA) Patients Consumers / patients, their representatives HealthCare Professionals Doctors, pharmacists, nurses, other professionals working with medicines Pharmaceutical Industry Marketing Authorization Holders (MAHs) and their affiliates Success

11. India Initiatives

12. Country level initiatives Nation-wide PV programme initiated by CDSCO in July, 2010 with AIIMS, New Delhi as the National Coordinating Centre (NCC) In April, 2011, the NCC was shifted to the Indian Pharmacopoeia Commission (IPC), Ghaziabad The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines. National Pharmacovigilance Week started in 2021, and we celebrated the 4 th NPW in 2024 (17-23 Sep) with theme – “Building ADR Reporting Culture for Patient Safety”

13. PvPI Goals Short Term Goals To develop and implement PV system in India To enroll all MCI approved medical colleges in the program covering entire India To encourage HCPs for reporting of adverse reactions Collection of case reports and data Long Term Goals To expand the PV programme to all hospitals (govt. & private) and centers of public health programs To develop and implement electronic reporting system (e-reporting) To develop reporting culture amongst HCPs To make ADR reporting mandatory for HCPs

14. PvPI Outcomes List of Monthly Drugs Safety Alerts issued by PvPI from March 2016 to 2020 42 alerts issued covering multiple drug/vaccine products 49 India specific drugs safety signals/PIL changes communicated to the NRA, CDSCO for taking appropriate regulatory action 30 Regulatory Actions based on PvPI recommendations (few examples) Acute Kidney Injury as an ADR into the prescribing information leaflet (PIL) of the Proton Pump Inhibitors (PPIs) marketed in India. Mouth Ulceration as an ADR into the PIL of Cefixime marketed in India Alopecia as an ADR into the PIL of Amlodipine marketed in India. Hypokalaemia & Bronchospasm as ADRs into the PIL of the FDC of Piperacillin and Tazobactam

15. Career prospectus PV offers a career that blends science, detective work, and the chance to make a real difference in people’s lives

16. PV Market & Growth As per a 2023 report published in Indian Journal of Pharmacology, ~ 15% annual growth in demand for PV professionals is expected Global PV market size valued at USD 7.32 billion in 2023, is projected to grow to USD 11.78 billion by 2030, exhibiting a CAGR of 7% ( Source: grandviewresearch.com ) India PV market size valued at USD 188.0 million in 2023, is projected to grow to USD 340.5 million by 2030, exhibiting a CAGR of 8.9% ( Source: grandviewresearch.com )

17. Job Opportunities 17 Case Processing: Collecting & evaluating data on ADRs. Signal Detection: Identifying new risks associated with medications. Periodic Safety Reports: Preparing periodic reports for regulatory bodies Key Activities QA, Audit & Inspection teams PV Agreements Certified Translators Medical Information Call Centers (MICC) Product Technical or Quality Complaints handling Regulatory Submissions Training & Learning Management Other Activities Drug Safety Scientist Drug Safety Trainee / Associate Pharmacovigilance Scientist Pharmacovigilance Officer Associate Medical Writer Medical Writer/Coder PV Agreement expert Medical Information Specialist Business Titles

18. Thinking of a Career in PV Good work/life balance Comparatively good payouts Ambient work environment Lot of learning & growth opportunities Actively contributing to patient safety & wellbeing What you should expect Sound medical knowledge (APHE, Pathophysiology, Pharmacology & Clinical Practice) Excellent communication skills Attention to detail Able to deliver on time with first time quality Positive attitude What industry expects from you

19. Common Challenges Lack of understanding the basics of PV Limited coverage in the curriculum / PV expertise in academia (UG students must opt for PV in 8 th sem ) Gap in the medical / scientific knowledge Insufficient computer knowledge (basic MS package) No guidance for interview preparation / appearing in job interviews without preparation Missing Relevant Skills Lack of professional connections/guidance

20. The Way Forward Networking Strong connections with seniors & industry experts Interview QnA , prepare well for the role

21. Is PV work Critical ! Why or Why not?

22. Closing Remarks Continuous learning is the minimum requirement for success in any field – Brian Tracy PV starts as early as CT and continues throughout the lifecycle of a drug Market growth and projection is phenomenal (both WW & India+) PV has a plethora of sub-domains to learn, grab an opportunity & contribute (apart from Case Processing, Signal Detection, Medical Writing) Academia and PV Industry are coming forward to spread awareness amongst students - collaboration programs, expert talks, conferences/webinars etc. Students/aspirants must take proactive measures, utilize available resources to be future ready ( PvPI , WHO-UMC, EMA, US-FDA) Need to understand and mitigate the gap between academic knowledge and professional requirements

23. All t he opinions expressed in the presentation are my own, and do not reflect the official position of my current/previous employer 

24. Thank you

25. Back-up slides

26. Points to Consider Positive attitude & Passion for patient safety Confidentiality Data Quality and Consistency Timelines and Compliance Effective Communication Continuous Improvement 27