Officer - Pharmacovigilance

2 days ago

India Jagdale Industries Full time

**Department **:Pharmacovigilance
- **Minimum Qualification **:M.Pharm / B.Pharm, Additional Qualification PG Diploma in Clinical Trails & Clinical Research
- **Relevant Experience **:2+ years
- **Preferred Gender**: Male
- **Job Location**: Juggat Pharma, Kumbalgodu.
- 1. Analyzing and preparing documents and updating to licensing authorities in case if any Adverse Drug Reactions (ADR) of marketed products received.
2. Conducting and documenting the Post Marketing Surveillance reports of the products in coordination with marketing team.
3. Prparing the Periodic Safety Updates Reports (PSURs) of the products periodically and furnishing the same to Licensing authorities.
4. Collecting and compiling the data of Phase I, Phase II, Phase III and Phase IV clinical trails from CRO (Clinical Research Organization).
5. Conductiong ongoing investigations, identifying and monitoring any previously unknown adverse effects and assessing whether action needs to be taken to improve safety of existing drug.
6. Preparing and writing reports, input of information to aggregate reports and other regulatory documents as needed.
7.Keping and updating knowledge of corporate policies and local regulations, guidelines and SOPs up to date as well as data entry conventions and search functions on the database;
8. In depth knowledge of national/regional regulatory legislatory legislation and guidelines.
9. Knowledge of the pharmacovigilance regulations.
10. Interpersonal skills in a cross - functional team.
11. Skilled at people management and controlling outsourced vendor (CRO) activities in a compliance /regulated field.
12. Capable of troubleshooting and managing multiple projects simultaneously.
13. Strong knowledge abd understanding of medical terminology and clinical development processes.
14. Problem solving and decision - making skills.
15. Data analysis, Compilation Skills.
16. Excelent organizational skills and capable of working efficiently.
17. Possess an excellent interpersonal, verbal and written communication skills.

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