DRUG SAFETY PHYSICIAN
₹40,000.00
Drug Safety Physician is a well paid, career opportunity within Pharmacovigilance organisations and is responsible for management of benefit-risk profile including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals etc. for assigned post-marketing products as well as products under clinical trials. A Drug Safety Physician is expected to demonstrate strong medical knowledge and analysis for ICSR reports, safety documents (e.g. PSURs/PBRERs, signal analysis, RSI, regulatory enquiries, risk management plans). In addition a strong knowledge regarding international regulatory requirements like ICH, European Pharmacovigilance legislation, FDA and CIOMS etc is required to be a successful Drug Safety Physician.
Product Description
DRUG SAFETY PHYSICIAN TRAINING MODULES
The training modules for Drug Safety Physician are defined as per the roles & responsibilities with Industry standards and include the real time practices of job functions.
KNOWLEDGE BASED:
- Pharmacovigilance System and Practices Globally
- Pharmacovigilance Industry Regulations
- Regulatory reporting in Pharmacovigilance – Expedited and Aggregate
- Sources of ICSRs
TECHNICAL BASED:
- ICSR Processing
- Pharmacovigilance Safety Database
- MedDRA Coding
- WHO-DD Coding
- Causality Assessment
- Medical Review of ICSRs – Procedure and Practices
- Quality Management
- Aggregate Reports – Introduction and Overview
- Writing & Review of Aggregate Reports – Medical Assessments, Recommendations, and Conclusions
- RSI Updates and Procedures
- Signal Detection and Analysis
MANAGEMENT BASED:
- Review of Pharmacovigilance technical and regulatory documents
- Handling Safety management plans
- Global Business Units and Functional Team Management and Communications with real time scenarios
- Medical interpretation and consistency to system documents, product labels, and adverse event case assessment etc.
Additional Information
| TRAINER | Experienced Pharmacovigilance Professional |
|---|---|
| ELIGIBILITY | MD, MBBS |
| DURATION | 80 hrs, 9 hrs/week |
| TRAINING RECOGNITION & ACCEPTANCE | WHO Pharmacovigilance Guidelines |
| TAKE AWAY | Training completion certificate |
| INTERNSHIP | Not available for online training |
