Dr. NIKITA SARASWAT

Dr. Nikita Saraswat is a University Gold Medalist with 14 years of academic and research experience.

Course available for 2 years after purchase

🎓 Eligibility (6 Months)

- MBBS (from India or abroad)
- MD / MS (any clinical or non-clinical specialty)
- BHMS / BAMS / BUMS
- Foreign Medical Graduates (FMGs)
- FMGE / NExT qualified candidates
- FMGE non-qualified candidates (for non-clinical, industry roles)
- MBBS or equivalent primary medical qualification from foreign countries recognized by the awarding institution
- Registered Medical Practitioners (where applicable)
- Final-year medical interns and graduates awaiting registration (subject to program guidelines)

Career Roles / Positions After Completion

- Graduates of this program can apply for roles such as:
- Drug Safety Physician
- Medical Reviewer – Pharmacovigilance
- Medical Officer – Drug Safety
- Safety Physician / Case Review Physician
- Signal Detection & Risk Management Associate
- Clinical Safety Reviewer
- Medical Advisor – Pharmacovigilance
- Global Safety Physician (Entry-Level / Associate)
- (Hiring companies include global CROs, pharmaceutical companies, biotech firms & MNCs)

Core Drug Safety & Pharmacovigilance
•	Introduction to Pharmacovigilance & Drug Safety systems
•	Global PV regulations (ICSR lifecycle, expedited reporting)
•	CIOMS, MedWatch, E2B (R3) concepts
•	Case processing workflow (end-to-end)
Medical Review & Physician Responsibilities
•	Role of physician in drug safety & medical review
•	Medical assessment of ICSRs
•	Seriousness, causality & expectedness assessment
•	Benefit–risk evaluation
•	Follow-up strategy & medical judgment
Adverse Event Evaluation
•	Clinical interpretation of AEs, SAEs & ADRs
•	Special situations (pregnancy, overdose, medication errors)
•	Product complaints & lack of efficacy
•	Narrative medical review writing
Signal Detection & Risk Management
•	Signal detection basics for physicians
•	Risk management plans (RMP)
•	Aggregate reports (PSUR, PBRER – overview)
•	Safety surveillance & benefit-risk monitoring
Regulatory & Compliance
•	Global regulatory requirements (US FDA, EMA, MHRA, CDSCO)
•	Safety data quality & compliance
•	Audit & inspection readiness

Generative AI for Drug Safety Physicians
•	AI-assisted case triage & medical review
•	Gen AI tools for narrative & assessment support
•	AI for literature review & signal evaluation
•	Ethical & compliant use of AI in PV
Career & Placement Support
•	Physician-focused resume & LinkedIn optimization
•	Interview preparation for Medical Reviewer roles
•	Mock medical review discussions
•	Direct guidance for Pharma & CRO entry

Course Highlights
•	100% LIVE interactive training
•	Physician-centric curriculum (non-theoretical)
•	Real-world case discussions
•	Small batches with individual mentoring
•	Industry-aligned training for Pharma & CRO roles
•	Gen AI integrated workflows
•	Placement & career transition guidance



Postgraduate Diploma in Drug Safety & Medical Review for Physicians

Buy this course in 5 instalments and start learning now.

Running tight on budget? 
Pay amount in instalments

Learn Medicine by Dr.Nikita

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    https://www.learnmedicinebydrnikita.in/courses/797993?utm_source=linkedin&utm_medium=social-link&utm_campaign=web-course-share

Hey! I’m learning with Learn Medicine by Dr.Nikita and you can too. Here’s a course you might like: Postgraduate Diploma in Drug Safety & Medical Review for Physicians by Dr. NIKITA SARASWAT
    https://www.learnmedicinebydrnikita.in/courses/797993?utm_source=copy-link&utm_medium=social&utm_campaign=web-course-share

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