PHARMACOVIGILANCE AGREEMENTS (PVAS) & SAFETY DATA EXCHANGE - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Drug Safety
 
Duration:
3 Weeks / 80 Hours
 
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Pharmacovigilance Agreements (PVAs) & Safety Data Exchange

Introduction – PV Agreements & Data Exchange

In today’s global pharmaceutical landscape, pharmacovigilance is rarely handled by one organization alone. Sponsors, partners, CROs, and licensing companies must establish Pharmacovigilance Agreements (PVAs) to define roles and responsibilities for safety reporting and ensure full compliance with regulatory expectations.

The PSDA program introduces learners to the essentials of PV agreements, safety data exchange mechanisms, and compliance requirements. It provides the knowledge needed to manage contractual safety responsibilities, oversee data exchange with partners, and prepare for audits or inspections where PVAs are a focal point.

Course Name :  Pharmacovigilance Agreements (PVAs) & Safety Data Exchange
Course Code :  PSDA
Experience Level :  Intermediate
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Medicine, or related disciplines
Student Category :  PV Associates, Regulatory Professionals, Compliance Officers, Clinical Operations Staff

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By the end of this course, learners will:

  2. Understand what Pharmacovigilance Agreements (PVAs) are and why they are required.
  3. Learn how PVAs define roles, responsibilities, and timelines for safety reporting.
  4. Explore the regulatory requirements for PVAs (FDA, EMA, ICH-GVP).
  5. Gain knowledge of Safety Data Exchange Agreements (SDEAs) and their role in licensing partnerships.
  6. Understand case data flow between partners (sponsor, CRO, MAH, licensee).
  7. Learn compliance challenges and audit findings related to PVAs and SDEAs.
  8. Review best practices for drafting, negotiating, and maintaining PVAs.
  9. Practice scenarios on signal communication and urgent case reporting obligations under PVAs.
Who Should Take This Course

This program is ideal for:

  1. Drug Safety / PV Professionals managing case reporting obligations
  2. Regulatory Affairs staff responsible for compliance contracts
  3. Quality & Compliance officers supporting audits and inspections
  4. CRO/Pharma employees engaged in licensing or global safety partnerships
Benefits & Outcomes
  1. Develop expertise in PVAs and SDEAs to manage contractual compliance.
  2. Be prepared for audits and inspections where PV agreements are reviewed.
  3. Improve collaboration across sponsors, CROs, and licensing partners.
  4. Strengthen job readiness for compliance, regulatory, and PV operations roles.
Career Pathways: After completing this course
  1. PV Compliance Specialist
  2. Safety Data Exchange Coordinator
  3. Regulatory Affairs Associate (PV focus)
  4. Quality & Compliance Officer
  5. Global Drug Safety Operations Associate

Curriculum & Modules

Modules
1. Introduction to PV Agreements & Legal Framework

2. Regulatory Requirements for PVAs (FDA, EMA, MHRA, ICH)

3. Key Components of a PVA (Responsibilities, Reporting, Timelines)

4. Safety Data Exchange Agreements (SDEAs) – Purpose & Scope

5. Case Data Flow in Partnerships (Sponsor ↔ CRO ↔ Licensee)

6. Expedited & Periodic Reporting Under PVAs

7. Communication of Signals & Safety Concerns

8. Common PVA Audit Findings & CAPA Strategies

9. Best Practices in Negotiating & Maintaining PVAs

10. Case Studies – Real-World PVAs & SDEA Scenarios
Getting in Touch:

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.