The process of drug development is generally divided into 2 stages: (1) New lead discovery (Preclinical Research) and (2) New product development (Clinical Development). Drug Safety – Pharmacovigilance Associate can work in Pharmaceuticals, Medical Device, Hospitals and research institutions, such as academic health government agencies and departments, contract research organizations/ centers. Their primary role is to identify safety and risk information, evaluate and report with regulatory authorities. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.
Our Programs are delivered in 3 Different ways for convenience of student:
• Pure Internet Program (PIP)
– A Self-Paced Online Program with Email Support
• Blended Internet Program (BIP)
– A Self-Paced Online Program with Email Support Provided (WebEx Online Classes)
• Blended Classroom Program (BCP)
– On-Site Faculty based Classes, along with Email Support (On-Site Class)
|Lessons: 14 Lessons||Duration: 06 Weeks / 175 Hours||Language: English|
Recommended: A Bachelor or master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry
Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources email@example.com to check on your eligibility. We will contact you. Q-tech’s objective is to provide you the right career pathway and advancement required to meet your career goals.
The Benefit Student Gains
1) Upgrading the Knowledge required.
2) Better Resume Placement for promising jobs.
3) Low Investment, high learnings
4) Learn from Anywhere, Anytime at your pace.
5) Job and Title Based Tasks as followed and Practiced in industry
6) Applying Concept into Real-time (Policies, governance and tools)
7) Work on Role Based Tasks followed and Practiced in industry
8) Mocks and Narratives for Client Discussions
9) Readiness to work with limited support
Our objective is to help students to meet the following career pathways. Typical Drug Safety / Pharmacovigilance Associate (DSA) Job Titles the candidates can apply after this training program are :
|SENIOR DRUG SAFETY / PHARMACOVIGILANCE JOB TITLES|
|Senior Drug Safety / Pharmacovigilance Associate||Occupational Health & Safety Specialist Senior|
|Operations Specialist, Drug Safety||Vendor Case Management Specialist|
|Pharmacovigilance Scientist||Quality Safety Manager|
|Drug Safety Specialist||Patient Safety Data Manager|
|Medical Safety Assessment Physician||Drug Safety Scientist|
|Case Medical Evaluator||Global Drug Safety Specialist|
The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Quality Assurance concepts towards Drug Safety in reference to roles and responsibilities performed by Drug Safety / Pharmacovigilance Associate. Core topics includes Role of DSA (Trials), Clinical Trial Safety Surveillance, Phase IV Trials and Pharmacovigilance, Introduction to Adverse Events, SAE Reconciliation, Characteristics of a Case, Sources of Individual Case Reports, Basics of Coding in Drug Safety, Case Narratives, Medical Review, Case Follow-up Approaches and Handling of Cases, MedDRA and Argus reporting, Drug Safety Data Extraction and Pre-processing. The course curriculum is designed to give an edge to obtain job opportunity in Drug Safety / Pharmacovigilance field.
ADVANCED DRUG SAFETY ASSOCIATE
LIST OF TOPICS
1. Medical Record Extraction
2. Adverse Events Case Processing
3. CIOMS Line Listing
4. Case processing and FDA Reporting for Medical Devices
5. Revision of SOP Quality Control Procedure
6. SAE Reconciliation
7. PSUR - Periodic Safety Update Reporting
9. Data Entry
10. Signal Detection
11. Labeling Edit check
12. Quality Control Procedure
13. Resolution of queries of pending cases
14. SUSAR – Suspected Unexpected Serious Adverse Reaction
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