Drug Safety Physician

About Course

Pharmacovigilance organisations regularly need Drug safety physicians for management of benefit-risk profile, Identification and investigation of safety signals for the assigned post marketing products. The benefit risk profile also includes Review and analysis of safety data from post marketing sources and from 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). Additionally they need strong knowledge regarding international regulatory requirements like ICH, European Pharmacovigilance legislation, FDA and CIOMS etc.

Course Learning Outcome

To manage benefit-risk profile including review and analysis of safety data.
To demonstrate strong medical knowledge and analysis for ICSR reports, safety documents (e.g. PSURs/PBRERs, signal analysis, RSI, regulatory enquiries, risk management plans)
To showcase strong knowledge regarding international regulatory requirements

Training Modules

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

Career Opportunities

• Fresher Level job in Pharmacovigilance is DSA (Drug Safety Associate). A Drug safety Associate is mainly involved in case creation, checking for MSI (Minimum safety information - a patient, a reporter, a suspect drug and a adverse event), reconciliation and follow up process, data entry of all information available in the document and medical coding

• 3 Years of experience builds more skill sets as (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc) which can bag him a position as DSS (Drug Safety Scientist).

• With a Certification in Pharmacovigilance and an overall of 5+ Years experience, candidates can become a Team lead or Team manager based on the company.

Eligibility

Graduates in any stream are eligible to apply for PHARMACOVIGILANCE Training Course.

Duration

3 Months

TAKE AWAYS

Training completion certificate
Recommendation letter for candidates with good performance in training

TRAINING RECOGNITION & ACCEPTANCE

WHO Pharmacovigilance Guidelines
International Conference on Harmonization
Good Pharmacovigilance Practices Modules

Apply Online

Students can download the admission form by clicking here, in PDF format print and fill the same, clearly mentioning Mobile No & Course Interested.