Master's in
Clinical Research &
Pharmacovigilance
A comprehensive 12-month Executive Master's program. Build career-defining mastery in ICH-GCP, leading safety database workflows, signal detection in R, and clinical trial data management.
● Curriculum aligned with ICH E2, GVP Modules & CDSCO GuidelinesProgram Overview Executive Tier
Tailored Career Pathways for Healthcare Professionals
Whether you are launching your life-sciences career or expanding your clinical judgment into corporate pharma, this curriculum provides the required technical credentials.
Translate your academic foundation into industry-ready skills.
Explore ICSR handling, clinical trial operations, safety reporting and structured data workflows.
Possible pathways: Drug Safety Associate · Clinical Research Coordinator · PV TraineeGrow into specialist clinical research and drug safety roles.
Deepen your applied knowledge of regulatory frameworks, audit-ready documentation and safety analytics.
Possible pathways: Safety Specialist · Clinical Data Analyst · Quality AssociateExtend clinical expertise into research and pharmaceutical safety.
Connect clinical judgement with pharmacovigilance, patient safety assessments and trial monitoring.
Possible pathways: Medical Reviewer · Clinical Research Associate · Safety Physician (subject to qualifications)Hold a postgraduate qualification? Add practical validated technical tools.
Pair your postgraduate theoretical foundation with practical software mastery in Oracle Argus database simulations, CDISC data standards, and statistical signal quantification in R.
Target career opportunities: Safety Scientist / Specialist · Lead CRA / Trial Monitor · Clinical Quality Auditor · Medical Writing SpecialistCheck Your Eligibility in 30 Seconds.
The Executive Master's is open to degree holders in Pharmacy, Medicine, Life Sciences, Nursing, and Biotechnology. Check your eligibility now and request the curriculum breakdown.
- Direct Brochure & Syllabus Access
- Admissions & Scholarship Consultation
- Internship Placement Pre-Screening
Admissions Eligibility Check
Select your academic background to submit your enquiry.
One Year. Three Semesters. Complete Mastery.
Designed with modular pacing allowing working professionals to excel alongside professional commitments.
SEMESTER 1 · 15 WEEKS
Pharmacovigilance & Drug Safety
Master regulatory safety frameworks, GVP, MedDRA/WHODrug coding, ICSR management, causality assessment, and quantitative signal detection.
10 Academic Credits · 2 Electives IncludedSEMESTER 2 · 15 WEEKS
Clinical Research & Operations
Trial design, ICH-GCP ethical compliance, eCRF/EDC database builds, edit check writing, discrepancy and query management, up to database lock.
10 Academic Credits · 1 Advanced ElectiveSEMESTER 3 · 15 WEEKS
Practicum, Internship & Capstone
Tool-based PV & Clinical Practicums, a 4-week industry placement (~90 workplace hours), and final capstone thesis presentation.
10 Academic Credits · Internship*Detailed Modular Curriculum
Semester 1: Principles & Practice of Pharmacovigilance
15 Weeks · 10 Credits · Core Safety Sciences
Foundations of Pharmacovigilance & Regulatory Frameworks
ICH E2 series, Good Pharmacovigilance Practices (GVP), FDA/EMA mandates, WHO-UMC, and CDSCO/PvPI systems.
ICSR Management, Causality Assessment & Signal Detection
MedDRA hierarchy, WHODrug coding, narrative writing, E2B(R3) transmission, SAE/SUSAR expedited reporting, and PRR/ROR.
Two Specialization Electives (Choose 2 of 6)
Global Regulatory PV & Audits, Vaccines & Biologics Safety, Materiovigilance & Device Vigilance, Digital PV & AI Safety Science, or Aggregate Safety Reporting (PSUR/PBRER).
Capstone Research Development & Midterm Assessment
Applied safety research hypothesis, structured protocol development, and end-of-semester examination.
Semester 2: Clinical Research & Operations
15 Weeks · 10 Credits
Clinical Trial Design & ICH-GCP
Ethics, trial protocols, informed consent, and regulatory conduct.
Clinical Data Management & EDC
eCRF builds, edit checks, data validation, discrepancy management, and database lock.
Clinical Monitoring & Advanced Elective
Trial monitoring workflows, quality oversight, and applied specialization.
Semester 3: Practicum, Internship & Capstone
15 Weeks · 10 Credits
Applied Safety & Clinical Practicums
Workflows and scenario-based simulation labs.
Industry Internship*
Planned 4-week placement (~90 workplace hours), subject to published academic and attendance conditions.
Capstone Thesis & Presentation
Applied research, final thesis preparation and presentation.
Learn the Software Workflows Used by Global CROs
Hands-on simulation of validated clinical and safety workflows.
Safety Database Environment
Case receipt, booking-in, MedDRA coding, adverse event seriousness grading, narrative generation, and E2B(R3) compliant export.
EDC & Clinical Data Management
Electronic Case Report Form builds, range validation rules, user acceptance testing (UAT), discrepancy flags and database lock protocols.
Signal Analysis with R
Analyze FAERS and MAUDE repositories. Calculate proportional reporting ratios and reporting odds ratios.
Global Reference Databases
DrugBank, VigiBase data structures, OpenFDA API streams and national PvPI/MvPI registries.
GVP VI Literature Surveillance
PubMed/Embase search strategies, journal publication assessment, and ICSR reporting triggers.
Applied AI in Clinical Trials
Explore how LLMs and automated intake triage affect safety databases and regulatory compliance.
Internship & Comprehensive Placement Support
Bridging academic qualifications and industry hiring standards with practical experience.
Industry Internship (4 Weeks)*
Students meeting academic standing and attendance conditions are allocated a planned 4-week workplace internship (~90 clock hours) with a healthcare, CRO, or clinical data organization.
- Real-world ICSR processing and clinical monitor shadowing
- Exposure to audit-ready SOPs
- Industrial certificate documentation
Placement Assistance & Industry Connect
Placement guidance described in the program proposal in partnership with PharmaBharat.
- Resume optimization for CRO opportunities
- Technical mock interviews
- Information about relevant hiring drives
Typical Roles & Compensation Benchmarks in India‡
Drug Safety Associate / CRC
ICSR processing, case narrative creation, site documentation.
Safety Scientist / Senior CRA
Causality reviews, monitoring site visits, audit compliance.
Signal Detection Specialist
Disproportionality evaluation, aggregate risk management plans.
Clinical Data Manager
EDC validation, edit checks, database lock governance.
Medical Reviewer / Safety Physician
Clinical risk-benefit evaluation and medical sign-offs; requires relevant medical qualification.
PV / Clinical Operations Lead
Global delivery oversight, sponsor audits, regulatory inspections.
‡ Indicative ranges reproduced from supplied design references; not independently verified. Actual compensation varies by qualifications, employer, location and experience.
IQVIA · ICON plc · Parexel · Syneos Health · Fortrea · Cognizant Life Sciences · TCS Pharma
Names shown as industry examples, not as confirmed placement partners.
Mentored by Practicing Industry Leaders
Learn from educators with regulatory inspection and senior clinical trial oversight experience.
Lead Safety Scientist
ICSR operations and aggregate safety reporting.
Clinical Project Director
Trial operations and site oversight.
Head of Data Management
CDISC standards and EDC architecture.
Regulatory Affairs Advisor
Regulatory submissions and dossiers.
Clear, Transparent Tuition With Flexible 24-Month Financing
The proposed one-time fee covers tuition, laboratory software, practicum assessments and internship placement.
- EMI plans up to 24 months, subject to lender eligibility
- Program tools and coursework included as advertised
- Confirm full payment terms with admissions before enrolment
Total Program Fee
Inclusive of all taxes, as shown in supplied design
Indicative EMI ≈ ₹3,959/month for 24 months*Apply & Reserve January 2027 Seat
*Financing depends on actual provider terms; ₹95,000 ÷ 24 is approximately ₹3,958.33 before financing charges.
Everything You Need to Know
Who is eligible for this Executive Master's program?
Graduates from Pharmacy, Medicine, Life Sciences, Nursing, Biotechnology and related backgrounds may enquire. Final eligibility is confirmed by admissions.
Can I pursue this program while working full-time?
The advertised mode is interactive hybrid, with live lectures and labs. Contact admissions for the current timetable and attendance requirements.
Is the 4-week industry internship guaranteed?
The supplied program design advertises a 4-week internship for eligible enrolled students subject to academic standing and attendance. Confirm terms in the official admissions agreement.
Which institution awards the final Master's degree?
The supplied program materials identify Commonwealth University, Saint Lucia, as the awarding institution. Verify the formal award details with admissions.
What are the financing and EMI payment terms?
The advertised fee is ₹95,000 and financing up to 24 months is mentioned. Actual instalments, charges and eligibility depend on the provider's final terms.
Advance Your Career in Global Clinical Sciences
January 2027 cohort enquiries are open. Contact admissions to confirm the latest enrolment timeline.
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