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Aggregate Report

Ahmedabad
Full-Time
Junior: 2 to 3 years
3L - 4L (Per Year)
Posted on Nov 21 2024

About the Job

Skills

PSUR
PABER
Aggregate Report
RMPs
PADERs
DSUR

• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for

submission to local and other Health Authorities.

• Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.

• Authoring of Signal Management Reports.

• Performing literature search and validity check for the aggregate reports.

• Reconciliation of relevant process trackers.

• Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).

• Generation of Line Listings (LL) from safety database

• Providing reliable support for high priority Ad-hoc activities.

• Ensure all the reports are drafted within the allocated timelines.

About the company

Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Inte ...Show More

Industry

Pharmaceutical Manufactur...

Company Size

51-200 Employees

Headquarter

Ahmedabad