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: 19 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 firstname.lastname@example.org 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 :
|DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES|
|Manager, Drug Safety and Pharmacovigilance||Manager, Drug Safety Science|
|Medical Operations Leader||Local Safety Manager (LSM)|
|Drug Safety Physician||Team Lead Quality & Safety|
|Therapeutic Area Lead||Safety Review Specialist – Literature team|
|Medical Reviewer||Medical Safety Manager|
Designed by industry experts for students and young professionals. 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.
ADDITIONAL DRUG SAFETY-PHARMACOVIGILANCE
LIST OF TOPICS:
1. Introduction to MedDRA
2. MedDRA Coding Guidelines- Part 1
3. MedDRA Coding Guidelines- Part 2
4. MedDRA Coding Guidelines- Part 3
5. MedDRA Coding Guidelines- Part 4
6. AE Causality assessments
7. ICSR Medical Causality assessment
8. Introduction to Risk Management Plan (RMP)
9. Introduction to Risk Management Plan (REMS)
10. Argus Safety End-User Training - Module 1
11. Argus Safety End-User Training - Module 2
12. Argus Safety End-User Training - Module 3
13. Argus Safety End-User Training - Module 4
14. Argus Safety End-User Training - Module 5
15. Product Quality Complaints (PTC / PQC)
16. Corrective and Preventative Actions (CAPAs)
17. Overview of Aggregate Reporting (PSUR/ PBRER)
18. Overview of Aggregate Reporting - PADER
19. Overview of Aggregate Reporting - PRAC / DSUR
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