Designation : Safety Medical Writer
Qualification : M. Pharm / B. Pharm / BAMS/BHMS/ BDS (Health care professional)
Location : Mumbai
Experience : 2 to 3 years of experience in drafting and reviewing of PADER, PSUR, PBRER and RMP
Experience in drafting and reviewing of PADER, PSUR, PBRER and RMP
• Preparation and quality review of various types of Aggregate Reports (AR)-PSUR, PBRER, Annual Safety Report, PADER, RMP.
. Strategizing and planning for submission of ARs. Kick-off meeting arrangement with client and relevant stakeholders (ICSR team etc).
• Generation of line listings and summary tabulations, referring the processed ICSR for ARs and XML from global safety database.
• Issue identification and resolution.
• Support in other departmental.
Interested candidates can share cv on email@example.com