*Roles and Responsibilities:
-Preparation of Risk Management Plan (RMP)
-Preparation of Periodic safety update reports (PSUR / PBRER)
-Preparation of Addendum to the Clinical Overview (ACO)
-Preparation of Periodic Adverse Drug Experience Report (PADER)
-Preparation of Development Safety Update Report (DSUR)
-Preparation of Signal Report
-Provide support in audits and inspections
-Prepare the documents as per SOPs & WIs

Qualification: BPharm / MPharm / MSc

Experience:
1-5 years of experienced candidate in RMP, PSUR, ACO, PADER, DSUR, Signal

*Knowledge and Skills:
-Excellent oral/written communication in English
-Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word

If you are interested, then please send your CV elc.hr@productlife-group.com