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Pharmacovigilance Certificate Course:
Master the Essentials of Drug Safety Management

Join PharmaState Academy’s intensive certification course in pharmacovigilance for a transformative learning journey with endless opportunities to explore.

This course offers industry relevant curriculum crafted by pharmacovigilance experts and explores the history, regulations, adverse reactions, safety databases, safety reports, narrative writing and various drug development intricacies related to pharmacovigilance. 

Prepare yourself for a dynamic future in pharmacovigilance and gain a competitive edge in your career prospects.

Pharmacovigilance Certificate Course: Master the Essentials of Drug Safety Management

Join PharmaState Academy’s intensive certification course in pharmacovigilance for a transformative learning journey with endless opportunities to explore.

This course offers industry relevant curriculum crafted by pharmacovigilance experts and explores the history, regulations, adverse reactions, safety databases, safety reports, narrative writing and various drug development intricacies related to pharmacovigilance. 

Prepare yourself for a dynamic future in pharmacovigilance and gain a competitive edge in your career prospects.

3 Months

12 Weeks Course Duration

Batch Starts

Oct 2023

Pharma Curated

Precise & Targeted Syllabus

Group Learning

Peer to Peer Discussions with 1-on-1 Mentoring

What will you get?

  • In-depth knowledge of PV’s historical evolution, safety regulations, and adverse event management
  • Proficiency in utilizing industry-standard safety databases and processing complex medical literature
  • Expertise in crafting safety reports, narrative, and summaries – giving a competitive edge in the pharma landscape

Who should attend?

  • Pharma students aspiring to specialize in pharmacovigilance.
  • Early professionals looking to transition into the field of pharmacovigilance.
  • Curious minds intrigued by drug safety and regulatory dynamics.

Why Should You Attend?

  • Professional Transformation: Experience a transformative learning journey that empowers you to excel as a pharmacovigilance professional
  • Acquire In-Demand Skill Set: Acquire the most relevant skill set which is the most demanded by the pharmaceutical industry
  • Dynamic Industry Entry: Gain entry into a pivotal industry integral to diverse sectors, backed by a substantial market size and immense growth potential.

Learning Outcomes

  • Expert Knowledge: An expert understanding of pharmacovigilance’s history, global safety guidelines, adverse event management and safety database utilization 
  • Proficient Skills: Proficiency in medical literature, coding adverse events using MedDRA dictionary, and crafting narratives & safety reports
  • Industry Readiness: Ability to ensure medication safety and contributing effectively to signal management and reporting processes

Course Syllabus

  • Uncover the Roots: Explore the fascinating evolution of pharmacovigilance.

  • Safety’s Significance: Grasp the critical role pharmacovigilance plays in drug safety.

  • Journey through Development: Gain insights into the intricate drug development process and clinical trials.

  • Adverse Adventures: Master the art of adeptly managing adverse drug reactions

  • Database Demystified: Dive deep into the world of safety databases like Argus and ArisG.

  • Data’s Driving Force: Understand their pivotal role in managing pharmacovigilance data.

  • Navigating Global Waters: Conquer global safety guidelines and regulations.

  • Masters of Regulation: Unveil the authority of GVP, ICH, and 21CFR in pharmacovigilance

  • Sourcing Safety: Delve into diverse safety report origins.

  • Literature Unleashed: Harness platforms like PubMed for dynamic literature processing.

  • Literary Insights: Attain advanced knowledge of literature databases and case processing.

  • Mastering Processing: Hone skills in efficiently handling safety cases from the literature.

  • Decoding MedDRA: Master the art of navigating the MedDRA dictionary and its coding intricacies.

  • Precision in Coding: Attain accuracy in coding adverse events for robust reporting.

  • Workflow Wonders: Grasp the nuances of diverse pharmacovigilance workflows.

  • Data Dominion: Become a data entry virtuoso within safety databases.

  • Workflow Wizardry Continues: Dive deeper into varied workflows and data entry strategies.

  • Mastery in Navigation: Become adept at traversing safety databases effectively.

  • Narrative Craftsmanship: Develop the art of crafting comprehensive narratives.

  • Articulate Adversities: Convey adverse events eloquently through the written word.

  • Periodic Prowess: Learn the intricacies of composing periodic safety reports.

  • Signal the Future: Understand the science behind PSUR, PADAR, PBRER, and signal management.

  • Summarizing Excellence: Master the skill of summarizing complex pharmacovigilance data.

  • Interview Ingenuity: Grasp interview techniques to extract crucial information effectively.

WEEK 1
History and Introduction to Pharmacovigilance

  • Uncover the Roots: Explore the fascinating evolution of pharmacovigilance.

  • Safety's Significance: Grasp the critical role pharmacovigilance plays in drug safety.

WEEK 2
Drug Development/Clinical Trials and Adverse Drug Reaction Handling

  • Uncover the Roots: Explore the fascinating evolution of pharmacovigilance.

  • Safety's Significance: Grasp the critical role pharmacovigilance plays in drug safety.

WEEK 3
Introduction to Various Safety Databases (Argus, ArisG)

  • Database Demystified: Dive deep into the world of safety databases like Argus and ArisG.

  • Data's Driving Force: Understand their pivotal role in managing pharmacovigilance data.

WEEK 4
Global Safety Guidelines/Regulatory Authorities (GVP, ICH, 21CFR)

  • Navigating Global Waters: Conquer global safety guidelines and regulations.

  • Masters of Regulation: Unveil the authority of GVP, ICH, and 21CFR in pharmacovigilance

WEEK 5
Introduction to Various Safety Report Sources and Literature Processing (PubMed, etc)

  • Sourcing Safety: Delve into diverse safety report origins.

  • Literature Unleashed: Harness platforms like PubMed for dynamic literature processing.

WEEK 6
Literature Databases and Processing (Case Processing)

  • Literary Insights: Attain advanced knowledge of literature databases and case processing.

  • Mastering Processing: Hone skills in efficiently handling safety cases from the literature.

WEEK 7
MedDRA Dictionary and Coding with It

  • Decoding MedDRA: Master the art of navigating the MedDRA dictionary and its coding intricacies.

  • Precision in Coding: Attain accuracy in coding adverse events for robust reporting.

WEEK 8
Different Work Flows and Data Entry of Safety Database-I (Workflow in Detail)

  • Workflow Wonders: Grasp the nuances of diverse pharmacovigilance workflows.

  • Data Dominion: Become a data entry virtuoso within safety databases.

WEEK 9
Different Work Flows and Data Entry of Safety Database-II (Workflow in Detail)
  • Workflow Wizardry Continues: Dive deeper into varied workflows and data entry strategies.
  • Mastery in Navigation: Become adept at traversing safety databases effectively.
WEEK 10
Narrative Writing
  • Narrative Craftsmanship: Develop the art of crafting comprehensive narratives.
  • Articulate Adversities: Convey adverse events eloquently through the written word.
WEEK 11
Periodic Safety Reports Writing/PSUR/PADAR/PBRER and Signal Management
  • Periodic Prowess: Learn the intricacies of composing periodic safety reports.
  • Signal the Future: Understand the science behind PSUR, PADAR, PBRER, and signal management.
WEEK 12
Summarization and Interview Procedure
  • Summarizing Excellence: Master the skill of summarizing complex pharmacovigilance data.
  • Interview Ingenuity: Grasp interview techniques to extract crucial information effectively.

Know Your Educator

Hashim Mansoori

Pharmacovigilance Expert

Hashim Mansoori is an experienced professional in the field of pharmacovigilance, with a wide range of expertise and experience in various cases. Throughout his career, he has worked with global Health Authorities (HAs), through which he has gained valuable knowledge and insights into global pharmacovigilance regulations and practices.

His extensive background in pharmacovigilance has equipped him with the skills to handle all types of adverse drug reactions (ADRs), medication errors, product quality complaints, and other related cases. He has a deep understanding of the reporting and documentation requirements, ensuring compliance with regulatory guidelines.

 

In addition to his case management expertise, Hashim also has a passion for sharing knowledge and empowering others in the field. He has been actively involved in providing pharmacovigilance training programs, both internally within organizations and externally to healthcare professionals and stakeholders. These training sessions cover a wide range of topics, including adverse event reporting, signal detection, risk management, and regulatory compliance.

 

With Hashim Mansoori’s broad experience in pharmacovigilance, exposure to various cases, and commitment to training and education, he is well-equipped to contribute to the safety and well-being of patients worldwide and support organizations in meeting their pharmacovigilance obligations.

Query Form

If you have any Query, please fill the form. 

Frequently Asked Questions

The Pharmacovigilance Certificate Course is a specialized educational program designed to provide comprehensive knowledge and training in the field of pharmacovigilance, which involves monitoring and assessing the safety of pharmaceutical products and ensuring their safe use.

There has been a strong strong shift in the ways the business is done in pharma due to impact of digital. The environment is becoming more & more digital with each passing day. This program will assist you to become more adaptable to digital environment.

Enrolling in a Pharmacovigilance certificate course can benefit your career by providing you with specialized skills and knowledge in drug safety and regulatory affairs. It enhances your employability in pharmaceutical companies, regulatory agencies, and clinical research organizations. Additionally, you get advantage over the non-certified candidates when it comes to hiring and other positional preferences.

The price of the Digi Pharma Pro is Rs. 50000/- but for the inaugural batch, you can enroll at Rs. 25000/- only (Govt. taxes extra).

Yes, there is EMI facility available on this program. The EMI option will appear during payment process.

*Please check the interest applicable on EMI during the payment process as per bank policies.

We understand that personal preferences and expectations can vary, and while we do not offer refunds, we are committed to ensuring your satisfaction with the program. If you find that the program does not align with your expectations, we encourage you to reach out to our dedicated faculty and support team. They are here to provide guidance, address any concerns you may have, and work with you to make the most of your learning experience. We believe that open communication and collaboration can often resolve any issues and help you find value in the program. Your success and satisfaction are important to us, and we are here to support you throughout your journey.

Yes, upon successful completion of the Pharmacovigilance certificate course, you should receive a certificate as recognition of your achievement. The certificate demonstrates your expertise in pharmacovigilance and can be valuable for your career.

Job assurance may not be guaranteed with the completion of a certificate course. However, we may offer placement assistance or career guidance to help you in your job search within the field of pharmacovigilance.

“Full 1-Year hand-holding support” typically refers to ongoing guidance and assistance provided by the course or institution for a period of one year after completing the program. This support may include career counseling, job placement assistance, or access to resources to help you transition into the workforce.

Yes, you can.

The course curriculum can vary, but it typically covers topics such as pharmacovigilance principles, regulatory requirements, adverse event reporting, signal detection, clinical trials and risk management. Specific modules may also include case studies and practical training.

Yes, you will be provided with course content throughout the course.

Yes, there would be opportunities where you will be interacting with industry professionals.

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