Proximsoft’s Comprehensive Pharmacovigilance Training
Welcome to Proximsoft’s Pharmacovigilance Training, your gateway to mastering the art of ensuring drug safety in the pharmaceutical industry. Our comprehensive course is designed by industry experts, offering you an in-depth understanding of pharmacovigilance practices, regulations, and methodologies. Whether you’re a seasoned professional or entering the field, our course provides the knowledge and skills needed to excel in pharmacovigilance.
Why Learn Pharmacovigilance?
- Ensure the safety of medicines in the market and contribute to public health.
- Understand global pharmacovigilance regulations and compliance requirements.
- Gain expertise in adverse event reporting, signal detection, and risk management.
- Acquire the necessary skills for a rewarding career in drug safety and pharmacovigilance.
- Our course covers essential aspects, from reporting and record-keeping to regulatory standards, ensuring a comprehensive learning experience.
| Mode of Training | Online live Interactive sessions |
| Duration of the Training | 6 weeks |
| Training duration per day | 60 – 90 min session |
| Software Access | Software will be installed/server access will be provided, whichever is possible |
| Training Materials | Soft copy of the material will be provided during the training |
| Training fee | Depends on the Requirement |
| Resume Preparation | Yes, at the end of the course based on the JD |
| Interview Preparation | Yes, by sharing some FAQ’s |
| Mock calls | Yes, 2 Technical Mock calls |
| Internship Project | Yes |
| Certification | Yes, at the end of the training |
| JOB Assistance | Yes |
| JOB Support | Yes |
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| Weekdays | 6AM -2 PM EST & 6-11:30 PM EST (student can pick any 1 hr) |
| Weekends | 8 AM – 12 PM EST (student can pick any 2 hrs) |
Course Content
Introduction to Clinical Research
- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Safety Reporting
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
- E2A- Clinical Safety and Data Management
- Media 436
- Naranjo Assessment
- Order and Formulate to Determine the Quantum
- SAE Reporting
- Safety Reporting- Quiz
Pharmacovigilance
- Overview of Pharmacovigilance
- History of Pharmacovigilance
- ADR Classifications
- Introduction to Aggregate Reporting
- AE_SAE Reporting Process
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FAQ'S
Pharmacovigilance ensures the safety of medicines post-launch, detecting and evaluating adverse drug reactions to protect public health.
Responsibilities include adverse event reporting, signal detection, risk management, and ensuring compliance with global pharmacovigilance regulations.
Absolutely! Our course caters to both beginners and experienced professionals, providing a solid foundation in pharmacovigilance practices.
Proximsoft offers career guidance, resume building to enhance their career prospects.
