MEDICAL SAFETY WRITER
₹40,000.00
Pharmacovigilance Medical Writers/Medical Safety Writers are amongst the most demanding professionals in the Pharmacovigilance industry where they play a crucial role at every stage of the drug development process. The industry requires highly skilled professionals for writing safety reports within agreed time frames and to a high standard of accuracy. The scope of the position starts from clinical development till post marketing activities and Pharmacovigilance medical writing is a necessary element at every stage. This generates the demand of specialized writers for successful submissions of regulatory documents in compliance with international guidelines.
Product Description
Medical Safety Writer – Online Training
This training program covers all the technical and regulatory aspects of Medical Safety Writer Job and the participant gets hands on experience on writing and review of various regulatory safety reports.
TRAINING MODULES:
CLINICAL DEVELOPMENT PHASE
- DSURs
- IND Annual Reports
- Clinical SAE narratives
MARKETING AUTHORISATION PHASE
- Summary of Clinical Safety (CTD Module)
- Clinical Overviews (overview of safety)
- EU RMPs
- US REMS
- Integrated Summary of Safety
POST-MARKETING PHASE
- EU PSURs/PBRERs
- US PADERS/PAERs
- 120-Day Safety Update Reports
- Clinical Overview Addenda (ACO)
- Ad hoc reports including safety reviews & summaries
- RSI variations & documentations
Additional Information
| TRAINING OUTCOMES | After the successful completion of the training, you will be given the tag of “CERTIFIED MEDICAL SAFETY WRITER” and you will be able to: |
|---|---|
| ELIGIBILITY | MBBS, BDS, M. PHARM, B.PHARM, MSc Life Sciences, M. Tech, Nursing + ICSR Processing Training/Experience |
| DURATION | 80 hrs, 9 hrs/week |
| TRAINING RECOGNITION & ACCEPTANCE | WHO Pharmacovigilance Guidelines |
| TAKE AWAY | Training completion certificate |
| INTERNSHIP | Not available for online training |
