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Aggregate Report

Ahmedabad
Full-Time
Mid-Level: 2 to 4 years
3L - 7L (Per Year)
Posted on Jun 20 2024

Not Accepting Applications

About the Job

Skills

Aggregate Report
PSUR
PADER
PABER
RMPs
RSI
Communication

Company


Pharmazone is fast Growing consulting Firm in GXP services, Regulatory affairs & Pharmacovigilance space. And we are looking forward to add some great assets to the Pharmacovigilance Team. In case this interests you, would love to connect.


Responsibilities

 

• 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.

 

For more information about Pharmazone kindly visit:- https://www.pharmazones.com/

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

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