Pharmacovigilance medical safety writing Course
DSUR,SCS, ISS,120 day safety update reports, PBRERs, PADERs, ADHOC safety review, ACO, PSUR addendum
Ratings 4.30 / 5.00
What You Will Learn!
- DSUR( Development Safety Update Report)
- SCS, ISS and 120 day safety update report
- Risk evaluation and management
- PBRER and PADER
- Other post marketing reports and Internal reports
- Teams involved in safety writing and sample case study
- Case study- Case summary analysis sample
Description
About Course:
Pharmacovigilance medical safety writing is most important process in every stage of drug development, approval and post marketing phase. This process require highly skilled people with clear understanding of regulation and guidelines as the reports should be very accurate and should be submitted as per timelines. PV medical safety writers are the most demanding professionals in PV sector due to the requirements from the authorities.
Main responsibilities of PV medical safety writers:
Writing periodic safety summary reports including collection, analyzing, preparing line listings, summary tabulations, drafting safety evaluations
Checking the format and content as per regulatory standards
Course Modules:
Introduction
Types of Pharmacovigilance documents
Pre-market : DSUR
Marketing Authorization phase: SCS, ISS, Risk evaluation and management documents, 120 day safety update reports
Post Authorization: PBRERs, PADERs, ADHOC safety review, ACO, PSUR addendum, Summary Bridging reports.
Teams involved in preparing the documents
Sample case study
TRAINING RECOGNITION & ACCEPTANCE
WHO Pharmacovigilance Guidelines
International Conference on Harmonization
Good Pharmacovigilance Practices Modules
Career opportunities:
1. As a fresher one can start their career in pharmacovigilance as drug safety associate/drug safety physician if you are a life science graduate or HCP. The role of Drug safety associates is mainly limited to ICSR processing.
2. With three years of experience you can be a part of signal management or aggregate writing/ PV medical safety writing teams.
3. For any team in pharmacovigilance process there will be two roles will be there one for other HCPs and one for Physicians.
4. With certification in pharmacovigilance and 5+ years of experience one can apply for management roles.
5. There are also other roles like QA and quality control teams, database admin in pharmacovigilance, based on interest and experience one can choose these positions.
Who Should Attend!
- Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences
- Graduate or postgraduate degree in Medicine
- Graduate or postgraduate degree in Chemistry (subject) .
- Pharmacovigilance early experience candidates