Senior Drug Safety Associate - Aggregate Reporting-Synowledge PV Services India Pvt Ltd

JOB TITLE: Senior Drug Safety Associate - Aggregate Reporting

LOCATION: Mysore, India.

YEARS OF EXPERIENCE: Minimum 2 years of experience in AR.

EDUCATION: Bachelors degree in Pharma/equivalent in a related discipline.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As Lead Author: 

 
Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements.
Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e. PSURs, PADER, DSURs, PBRERs, Addendum to Clinical Overviews, Addendum to PSURs, Summary Bridging Reports and RMP Updates).
Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.
Compile the safety data into the relevant sections of periodic reports such as PBRER, PADER, and DSUR according to the client.
Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal deduction.
Create all documents in accordance to all applicable SOPs, and convention of the client.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
Provide word and PDF versions of the final signed documents to the client.
Participate in internal and external audits and inspections by clients and health authorities.

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