Pharmacovigilance & Medical/Scientific Writings
Pharmacovigilance & Medical/Scientific Writings Syllabus
PHARMACOVIGILANCE & MEDICAL SCIENTIFIC WRITING
Global Institute of Health Science is a pioneer in health science education, especially in distance and online learning. The institute is ISO 21001:2018 certified and globally acclaimed, with copyright approval from IPR Government of India and international certification from UASL UK for Quality Control Management Systems.
The GIHS Advantage
- Bringing Excellence to Health Professionals
- 15+ Years of Experience with International Exposure
- Internationally Acclaimed with ISO & Government Approval
- Lifetime Free Personalized Tutoring for Student Success
Pharmacovigilance Training Program also known as Drug Safety. This is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function monitored by the physicians. Medication errors such as overdose, and misuse and abuse of a drug, are also of interest because they may result in an ADR. This GIHS Pharmacovigilance Program designed to provide total overview and skill globally in the field of clinical research and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. This program will enhance you on medical & scientific writings, you will be expert in Medical writing which involves the development and production of print or digital documents that deal specifically with medicine or health care. The profession of medical writing calls for knowledge in both writing and science, combining a writer’s creative talent with the rigor and detail of research and the scientific process.
Syllabus
- Introduction of Pharmacovigilance
- Overview of Pharmacovigilance
- Standard Terms and Terminology in Pharmacovigilance
- Medical Evaluation of Adverse Events in Pharmacovigilance
- Adverse Event Reporting System and Form
- Diagnosis and Management of ADRs
- Medical Evaluation of Adverse Events (AE)
- Case Processing
- Global Perspective of Pharmacovigilance
- Single Case Processing
- Case Narrative Writing
- Pharmacovigilance Reporting Database, Signal Detection, Management and Risk Assessment
- Quality System in Pharmacovigilance
- Expedited Reporting Criteria
- PSUR & PBRER
- PV Database and Signal Detection
- Risk Assessment & Management
- Medical Dictionary for Regulatory Activities (MedDRA)
- MedDRA
- Pharmacovigilance Laws and Guidelines
- Regulatory Guidelines & Laws in PV
- SOPs in PV
- PV Auditing and Inspection
- Regulatory Aspects in PV
- Medical / Scientific Writing
- Disease Management
- Continuing Education and Training
- Medical Reference and Information Gathering
- Practice Management and Monitoring
- Correct Spelling, Grammar, and Punctuation
- Copyediting for Accuracy, Clarity, and Flow
- Ensure Correct and Consistent Data across Texts and Graphics
- Ensure Compliance with Guidelines and Standards
Pharmacovigilance & Medical/Scientific Writings
Pharmacovigilance Training Program also known as Drug Safety. This is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function monitored by the physicians. Medication errors such as overdose, and misuse and abuse of a drug, are also of interest because they may result in an ADR. Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. This GIHS Pharmacovigilance Program designed to provide total overview and skill globally in the field of clinical research and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. This program will enhance you on medical & scientific writings, you will be expert in Medical writing which involves the development and production of print or digital documents that deal specifically with medicine or health care. The profession of medical writing calls for knowledge in both writing and science, combining a writer’s creative talent with the rigor and detail of research and the scientific process. Medical communicators may be writers, editors, health care journalists, supervisors, project managers, media relations specialists, educators, and more.
Course Objective
This GIHS Program would help you to gain in-depth knowledge on the best way to collect and report adverse events and safety data and manage the risk associated with and risk to pharmaceutical and nutraceutical products. Its unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety or pharmacovigilance program. These short and best medical writing courses online, pharmacovigilance course online and drug safety courses online include examination and diploma certification to aid freelance to one’s career in healthcare field.
Eligibility
- All Science Graduates, MBBS, BDS, BHMS, BAMS, BPT, BUMS, B. Pharm, M. Pharm, Pharmacy, Occupational Therapist, B.Sc., M.Sc., Life science, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech and all professionals working with Hospitals & Healthcare Organizations.
Mode or Methodology
- Online & Distance Learning
Certification
- GIHS Certificate would be awarded to only successful candidates.
Examination
- Online & Distance Exams (MCQ / Theoretical) / Projects
Placement Assurance
- Successful candidates would get the placement support. CVs of successful candidates would be forwarded to various Organizations.
Career Options
Drug safety specialist
Pharmacovigilance Associate
Drug Safety Associate
Medical Monitors
Fees, Payment & Program Duration
Certificate Program
- Duration : 3 Months
- Foundation-level program
- Core concept learning
- Industry awareness focus
- Expert-designed syllabus
- Research-based curriculum
- Academic & tech support
- Skill development course
- Govt-recognized program
- Global accreditation & recognition
- Globally ISO certified
- ₹22,999 For Indian Candidates
- $450* USD For International Candidates
Post Graduate Diploma Program
- Duration : 1 Year
- Advanced-level professional course
- Comprehensive concept mastery
- Research-based modules
- Lifetime expert support
- Job & career assistance
- Free Career Boost (www.TopCVCoach.com)
- High employment potential
- Govt-recognized program
- Global accreditation & recognition
- Globally ISO certified
- ₹32,999 For Indian Candidates
- $699* USD For International Candidates
*Fees subject to taxes & exchange rates.
Fast Track PG Diploma Program
- Duration : 4 Months
- Accelerated PG-level program
- Flexible learning format
- Self-paced completion
- Lifetime expert support
- Research-driven curriculum
- Free Career Boost (www.TopCVCoach.com)
- Job-oriented training
- Govt-recognized program
- Global accreditation & recognition
- Globally ISO certified
- ₹36,999 For Indian Candidates
- $750* USD For International Candidates
*Fees subject to taxes & exchange rates.
- Cheque / Demand Draft / Cash in the name of “Global Institute of Health Science”
- Online Transfer through NEFT or RTGS
- Fee can also be deposited in GIHS bank account
- Disclaimer: This course details are for the purpose of awareness about the program and career opportunities. The exact information on course structure may vary from this information.
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I would highly recommend this institution.


I am grateful for the opportunity to pursue the PG Diploma in Health Informatics & Management at GIHSS. Throughout the course, I learned a wealth of knowledge that has significantly enhanced my understanding of the healthcare industry and the role of technology in improving patient care.
The curriculum was comprehensive, covering essential topics such as health information systems, data management, healthcare analytics, and health policy. The faculty were highly experienced and supportive, always ready to clarify doubts and encourage practical learning. The program also emphasized real-world applications, which helped me develop critical skills needed in the healthcare sector.
Thanks to GIHSS, I now have a solid foundation in health informatics, enabling me to contribute effectively to healthcare organizations. Overall, this course has been a valuable stepping stone in my professional development, and I highly recommend it to anyone interested in bridging healthcare and technology.
Wishing everyone success in their learning journey! Best wishes to all future students.
Sincerely
Denis

Frequently Asked Questions
Medical writing in pharmacovigilance involves creating clear and accurate documents related to drug safety and regulatory reporting. This includes writing safety narratives, periodic safety update reports, and other relevant documents.
To get a pharmacovigilance certificate, you can enrol in online courses or training programs such as the one offered by us at GIHS. Our program covers topics such as drug safety, adverse event reporting, regulatory requirements, and pharmacovigilance systems.
Yes, a pharmacovigilance certificate is worth it, especially for individuals seeking to advance their careers in drug safety and regulatory affairs. Certification demonstrates a commitment to professional development and can enhance job prospects in the pharmaceutical and healthcare industries.
To become a pharmacovigilance scientist, you need a relevant scientific or medical background. Continuing education in pharmacovigilance and obtaining relevant certifications can further enhance your qualifications.
To become a medical writer, you need an educational background in a relevant field such as life sciences, pharmacy, or medicine. Specialized courses or certifications in medical writing can also be beneficial for career advancement.
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