🎓 Drug Safety & Pharmacovigilance Certification Programs

Offered by Qtech-Sol Professional Development Center

🔹 Introduction

Drug Safety and Pharmacovigilance are vital for ensuring patient safety throughout the drug development and post-marketing lifecycle. As pharmaceutical regulations tighten and real-world data grows in complexity, the demand for trained safety professionals continues to rise.

Qtech-Sol offers structured, role-based certification programs tailored for students, professionals, and career changers. These programs focus on practical learning, simulated case tasks, and job preparation across various drug safety roles—from assistant to medical reviewer level.

🌟 Best-Fit Program Finder

At Qtech-Sol Professional Development Center, we know every learner’s journey is unique. That’s why we’ve built this Best-Fit Program Finder to match your education, experience, and career goals with the right training program.

Whether you’re a student, career changer, or working professional, our tool helps you quickly discover the program best suited to your background.

🔹 Option A — Manual Filters
Select your Education Major, Level, Experience, Student Category, and Domain from the dropdowns, then click Show Programs to see your best-fit training options.

🔹 Option B — Resume Parse
Paste or upload your resume (Word/PDF), and our AI parser will extract your details to recommend the most relevant programs. Click Parse & Recommend to view suggestions.

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🔹 Available Certification Programs

1. Drug Safety Assistant (DSAA — Support Level)

  • Level: Support-level (Diploma, BSc)
  • Duration: 5 weeks / 130 hours
  • Curriculum:
    • Intro to PV & safety systems
    • Case intake triage & data entry basics
    • MedDRA coding fundamentals & code search
    • Seriousness/expectedness basics; clock start/stop
    • Quality checks, follow-ups & email etiquette
  • Format: LMS lessons, guided labs, quick checks

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2. Drug Safety Associate (DSAT — Case Processing)

  • Level: Entry–Intermediate (BSc/BSN/PharmD)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • End-to-end ICSR case processing workflow
    • MedDRA & WHO-DD coding; causality assessment
    • Narrative writing & medical query handling
    • Expedited reporting (7/15-day) & local regs
    • Duplicate detection & literature case intake
  • Format: LMS lessons, case sims, narrative labs

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3. Advanced Drug Safety Associate (ADSA — Advanced Processing)

  • Level: Advanced (MSc/PharmD/MD/Experienced DSAT)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Complex cases (special situations, pediatrics, pregnancy)
    • Quality metrics, CAPA & peer review frameworks
    • Aggregate reporting inputs (PBRER/PSUR/DSUR)
    • Signal triage/validation hand-offs & KRI usage
    • Partner reconciliation & vendor oversight basics
  • Format: LMS lessons, advanced case studies, capstone

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4. Drug Safety Role Based Projects (DSAP — Projects)

  • Level: Project-based (All levels; best after DSAT)
  • Duration: 6 weeks / 150 hours
  • Curriculum:
    • Mini-case series processing & reconciliation
    • MedDRA recoding & QC; deviation log & CAPA
    • Mock PSMF contribution & audit response pack
    • Aggregate narratives & line-listing QC drill
    • Inspection dry-run & interview simulation
  • Format: Guided projects, submissions, mentor feedback

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5. Drug Safety Medical Reviewer (DSMR — Medical Review)

  • Level: Advanced (MD/PharmD/Experienced clinical)
  • Duration: 10 weeks / 220 hours
  • Curriculum:
    • Medical review of ICSRs & narrative refinement
    • Expectedness/labeling, seriousness & case strategy
    • Medically significant events & benefit-risk notes
    • Signal evaluation inputs & RMP touchpoints
    • Stakeholder communication & oversight letters
  • Format: LMS lessons, reviewer labs, case boards

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6. Signal Detection & Risk Management (SDRM)

  • Level: Intermediate–Advanced (2+ yrs in PV/related)
  • Duration: 4 weeks / 90 hours
  • Curriculum:
    • Disproportionality basics & thresholds
    • Signal triage/validation & documentation
    • Benefit-risk frameworks & risk minimization
    • KRIs/KPIs, dashboards & governance
    • Cross-functional safety review meetings
  • Format: LMS lessons, tool demos, signal briefs

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7. PV Audit & Inspection Readiness (PVAIR)

  • Level: Intermediate–Advanced (3+ yrs / Leads)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • SOP/PSMF alignment & readiness checklists
    • Inspection logistics, storyboards & mock Q&A
    • Finding management & CAPA effectiveness
    • Partner/vendor oversight documentation
    • Common observations & remediation practice
  • Format: LMS lessons, mock audits, readiness drills

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8. Introduction to Pharmacovigilance & Drug Safety (IPVDS — Essentials)

  • Level: Essentials (All levels)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • PV lifecycle, stakeholders & systems landscape
    • ICSR vs aggregate safety reporting
    • Global regulations & compliance overview
    • Roles, tools & terminology (EDC, safety DB, MedDRA)
    • Career paths & competency map
  • Format: LMS lessons, quizzes, orientation tasks

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9. Basics of AEs & SAEs (AESSAE — Foundations)

  • Level: Essentials (All levels)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • AE/SAE definitions & seriousness criteria
    • Causality & expectedness fundamentals
    • Special situations & pregnancy cases
    • Medically important events & follow-ups
    • Source data & documentation standards
  • Format: LMS lessons, case vignettes, quizzes

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10. Understanding ICSR (ICSR — Core Case Fields)

  • Level: Essentials–Intermediate (Case processors)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • ICSR data fields & validation rules
    • Narrative structure & consistency tips
    • Medical queries & reconciliation practices
    • Duplicate checks & product dictionaries
    • Submission readiness & QC checklists
  • Format: LMS lessons, form labs, practice cases

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11. MedDRA & WHO-DD Coding – Basics (MEDDRA)

  • Level: Essentials–Intermediate (Coders/Processors)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • MedDRA hierarchy, PT/LLT selection rules
    • Versioning, SMQs & impact assessment
    • WHO-DD product coding essentials
    • Coding conventions & QC audit trail
    • Recode strategy & change control
  • Format: LMS lessons, coding labs, version drills

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12. Case Intake & Case Processing Workflow (CASE)

  • Level: Essentials–Intermediate
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • Intake channels & source verification
    • Clock start/stop & seriousness triage
    • Data entry standards & reconciliation
    • Follow-up strategy & correspondence logs
    • Hand-offs to medical review & submissions
  • Format: LMS lessons, workflow labs, templates

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13. Expedited Reporting Timelines (7/15 rules) (EXPED)

  • Level: Essentials–Intermediate (Reg reporting)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • Global expedited rules & local variations
    • Clock calculation, late case rationale
    • E2B readiness checks & error prevention
    • Partner submissions & reconciliation
    • Metrics, dashboards & escalation paths
  • Format: LMS lessons, timeline drills, quick checks

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14. E2B (R3) ICSR Submissions & Compliance (E2B)

  • Level: Intermediate (2+ yrs in PV/Reg)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • R2→R3 mapping & mandatory fields
    • Schema validation & common XSD errors
    • Gateway/portal submission workflows
    • NullFlavor, follow-ups & amendments
    • Compliance metrics & casebook audits
  • Format: LMS lessons, validator labs, submission sims

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15. PV Agreements (PVAs) & Safety Data Exchange Agreements (SDEAs) (PVASDEA)

  • Level: Intermediate (QA/RA/PV Ops)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • PVA/SDEA structures, roles & obligations
    • Safety data exchange terms & timelines
    • Deviation handling, breach & escalation
    • Partner oversight & audit readiness
    • Change control & renewals governance
  • Format: LMS lessons, template labs, negotiation drills

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🛠️ Learning Features & Support

  • Fully self-paced AI-powered LMS access
  • Role-based tasks, quizzes, case studies, and scenario-based evaluations
  • Final exam + Certificate of Completion
  • Optional Resume Marketing Services (RMS): Resume optimization, LinkedIn support, mock interviews, and job search strategy

✅ Why Join Qtech-Sol?

  • ✔️ Structured, role-based curriculum aligned to real-world job duties
  • ✔️ Practical simulations using standard regulatory practices (FDA, EMA, Health Canada)
  • ✔️ Training in MedDRA, WHODrug, CIOMS, and Argus Safety workflows
  • ✔️ RMS job support services with career advisors
  • ✔️ Courses tailored for entry-level to advanced professionals
  • ✔️ Modular learning suited to working professionals and career changers

🔜 Next Steps