Short course · 20 hours · Clinevo Safety
Pharmacovigilance Database Training
Learn to work in a real safety database. In 20 hours you practise on Clinevo Safety: you enter cases, code them, write short case write-ups and judge what caused each event. That is the daily work of a Drug Safety Associate.
- Duration
- 20 hours
- Mode
- Online + Classroom
- Next batch
- Every month
- Certificate
- BCRI certificate
Course fee₹18,000₹22,500
- LSSSDC · NSDC · Skill India training partner
At a glance
What is pharmacovigilance database training?
BCRI’s pharmacovigilance database training is a 20-hour hands-on course on the Clinevo Safety database. You practise every step of a case, from intake and data entry to coding, write-ups and causality. Then you work on case projects. It is for people who already know PV basics. Classes run live online or at HSR Layout, Bangalore. The fee is ₹18,000, and you get a BCRI certificate.
Drug safety teams record every side-effect case in a safety database. Knowing the theory is not enough. Employers want people who can handle a case in a real system.
This course gives you that practice on Clinevo Safety, a cloud-based drug safety system. You work through cases from start to finish, with a trainer guiding each step.
The steps you learn are the same in other systems, such as Oracle Argus Safety, ArisGlobal LifeSphere and Veeva Vault Safety. So your skills carry over.
Last updated
Why BCRI
Why choose BCRI for your safety database training?
Real safety database
Guided hands-on practice on the Clinevo Safety platform.
Full case workflow
Intake, data entry, coding, narratives, seriousness, expectedness and causality.
Case projects
Work on real-life style cases to build confidence for interviews.
Short and focused
Twenty hours — ideal after a pharmacovigilance course.
Online or classroom
Live online or at HSR Layout, Bengaluru, Monday to Friday.
Recordings for online batches
Online batches can revisit sessions for 3 months on the BCRI app.
Skills you gain in safety database training
- Navigate the Clinevo Safety database for case entry and processing
- Process Individual Case Safety Reports (ICSRs) from intake to completion
- Code adverse events and medical history with standard terminology
- Write clear, compliant case narratives
- Assess seriousness, expectedness, causality and reportability
- Understand how safety data feeds analytics and signal detection
- Explain how cases are submitted to regulators through secure gateways
Curriculum
Pharmacovigilance database training syllabus
Seven modules over 20 hours, ending with hands-on case projects.
- Modules
- 7
- Topics
- 19
- Duration
- 20 hours
Want the detailed syllabus?
An advisor will share the full module plan on WhatsApp or email.
Get the syllabus1
Introduction to pharmacovigilance (2 hours)
3 topicsA quick refresher on PV and its global rules.
- Why pharmacovigilance matters
- The global regulatory landscape
- Where the safety database fits
2
Safety database walkthrough (3 hours)
3 topicsGetting comfortable in the Clinevo Safety platform.
- Navigating the cloud-based platform
- Case screens and workflow
- User roles and case status
3
Individual Case Safety Reports (4 hours)
3 topicsHands-on ICSR processing.
- Case intake and validity
- Data entry and processing
- Managing follow-ups and duplicates
4
Medical coding and narrative writing (3 hours)
3 topicsAccurate coding and clear narratives.
- Coding medical terms with standard dictionaries
- Structure of a case narrative
- Writing quality narratives
5
Expectedness, causality and relatedness (4 hours)
3 topicsAssessing each case.
- Seriousness and expectedness checks
- Causality and relatedness assessment
- Reportability decisions
6
Analytics and signal detection (2 hours)
2 topicsFrom cases to insights.
- Case tracking and reports
- Basics of safety signal detection
7
Project work and case studies
2 topicsPutting it all together.
- End-to-end case projects on Clinevo Safety
- Review and feedback from the trainer
Fees & batches
Pharmacovigilance Database Training fees and upcoming batches
Course fee
₹18,000₹22,500Save ₹4,500
20 hours · Live online or classroom (HSR Layout, Bangalore)
What’s included
- 20 hours of live, trainer-led classes
- Guided practice on the Clinevo Safety database
- Case projects and assessments
- Recordings for online batches (3 months)
- BCRI certificate
Paying the full fee online? Choose “Pay in full online” when you apply and get 5% off. Basic pharmacovigilance knowledge is required before you join.
Compare all course fees →Upcoming batches
New batches start every month — online and at HSR Layout.
Classes run Monday to Friday. Ask an advisor for the next start date.
- Monday–Friday classes
- Recordings for online batches
- Online or HSR Layout, Bengaluru
- Instalment options available
Certification
Safety database training certificate
On completion you receive a BCRI certificate in Safety Database Training (Clinevo), showing hands-on experience in safety case processing.
This short course is not part of BCRI’s Dual Certification. For a full drug safety qualification, combine it with our pharmacovigilance training.
What your certificate shows
- Certificate of CompletionIssued by Bangalore Clinical Research Institute
- Core modules completedClinevo Safety database · ICSR processing · Coding & narratives · Causality assessment
- Registration numberUnique to you and verifiable online
Recognition marksISO 9001:2015
Careers & salary
Careers after safety database training
Hands-on database skills make you stronger for case processing and safety data roles:
Job roles you can apply for
- Drug Safety Associate
- Pharmacovigilance Associate
- Case Processing Specialist
- Safety Data Specialist
- Clinical Safety Associate
- Medical Information Specialist
Where you can work
- Contract research organisations (CROs)
- Pharmaceutical and biotech companies
- PV service providers
- Healthcare organisations
Hiring locations
- Bengaluru
- Hyderabad
- Pune
- Mumbai
- Chennai
- Remote roles
Typical career progression
- 1
Entry
Drug Safety Associate · Case Processor
- 2
2–4 years
Senior DSA · Quality Reviewer
- 3
4–7 years
Aggregate Report Specialist · Signal Analyst
- 4
Leadership
PV Team Lead · PV Manager
Salary range — market data
| Role | Experience | Typical salary | Source |
|---|---|---|---|
| Drug Safety Associate · India | 0–4 years | ₹3.8 – 4.2 lakh per year | AmbitionBox, 3.5k salaries, updated 8 Oct 2026 |
Figures are third-party market data for these roles, not BCRI placement outcomes. Actual pay depends on the employer, skills, certification and interview performance.
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Is this course right for you?
Talk to a BCRI advisor about eligibility, batches, fees and career paths. It’s free and there’s no obligation.
FAQs
Pharmacovigilance Database Training — frequently asked questions
What is a safety database in pharmacovigilance?
It is the system drug safety teams use to record, check and report side-effect cases. It helps safety data reach regulators correctly and on time.
Which safety database will I learn?
Clinevo Safety, a cloud-based, regulatory-compliant pharmacovigilance system covering case intake, processing, analytics and regulatory submissions.
Will this help me work on Argus or other databases?
Yes. The steps are the same in other systems, such as Oracle Argus Safety, ArisGlobal LifeSphere and Veeva Vault Safety. Your skills carry over.
How long is the course and what does it cost?
It is 20 hours. The fee is ₹18,000 (list price ₹22,500). Paying the full fee online when you apply gives 5% off.
Do I need pharmacovigilance knowledge first?
Yes. You should already know how side effects are reported, sorted and coded. If you are new to PV, start with our pharmacovigilance training.
Is it online or in the classroom?
Both. Join live online or at our HSR Layout classroom in Bangalore. Classes run Monday to Friday, and online batches get recordings for 3 months.
Will I get a certificate?
Yes. You receive a BCRI certificate in Safety Database Training (Clinevo). It is not part of BCRI’s Dual Certification.
What jobs can I apply for after this course?
Drug Safety Associate, Pharmacovigilance Associate, Case Processing Specialist and similar safety data roles at CROs, pharma companies and PV service providers.