Pharmacovigilance medical safety writing Course

Pharmacovigilance Medical Safety Writing: Master the Art of Drug Safety Documentation

🎓 About Course: Dive into the critical world of Pharmacovigilance (PV) and master the art of medical safety writing with our comprehensive course. This is an essential process that spans every stage of drug development, approval, and post-marketing. PV Medical Safety Writers are highly sought-after professionals due to their pivotal role in ensuring public health by providing accurate and timely safety reports as mandated by regulatory bodies.

Key Responsibilities:

• ✅ Periodic Safety Summary Reports: From collecting, analyzing, preparing line listings, summary tabulations, to drafting safety evaluations – you'll learn the intricacies of it all.
• ✅ Regulatory Compliance Checks: Ensuring that all documents are formatted and content-wise in alignment with global standards is critical for regulatory success.

Course Modules:

1. Introduction to Pharmacovigilance Documentation
2. Types of PV Documents
   • Pre-market: Daily Safety Update Report (DSUR)
   • Marketing Authorization phase: Suspensive Conditions Specifications (SCS), Integrated Risk Management Strategy (ISS), Risk Evaluation & Management documents, 120 day safety update reports
   • Post-Authorization: Periodic Benefit to Risk Reports (PBRERs), Periodic Adverse Drug Reaction Reports (PADERs), Ad Hoc safety reviews, Annual/Periodic Core Data Sheet addendum, Summary Bridging reports
3. Teams Involved in Document Preparation
4. Real-World Case Study Analysis
5. Recognition & Acceptance of Training:
   • 🌏 WHO Pharmacovigilance Guidelines
   • ⚛️ International Conference on Harmonization (ICH)
   • 📖 Good Pharmacovigilance Practices (GVP) Modules

Career Opportunities:

1. Start Your Journey: As a fresher, begin your career in pharmacovigilance as a Drug Safety Associate/Drug Safety Physician if you're a life science graduate or healthcare professional (HCP). The role primarily focuses on Individual Case Safety Reports (ICSR) processing.
2. Growth & Specialization: With three years of experience, transition to roles within signal management or specialize in PV medical safety writing teams.
3. Roles for HCPs vs. Physicians: Each team within pharmacovigilance will have distinct roles tailored for other HCPs and specialized physician positions.
4. Management Positions: With certification in pharmacovigilance and over five years of experience, apply for leadership roles within the PV process.
5. Diverse Roles: Choose from a variety of other positions such as Quality Assurance (QA), quality control teams, or become a database administrator in pharmacovigilance based on your interest and expertise.

Join our course today to embark on a rewarding career in Pharmacovigilance Medical Safety Writing – where every report you write contributes significantly to global public health safety. 📚✍️🚀