Opportunity to work as Pharmacovigilance Services Analyst at Accenture- Apply before 30th June 2024


Website Accenture

About Accenture

Accenture is a leading global professional services company renowned for its expertise in digital, cloud, and security solutions. With a robust presence across over 40 industries, Accenture provides a comprehensive suite of services including Strategy and Consulting, Technology and Operations, and Accenture Song. This extensive portfolio is supported by the world’s largest network of Advanced Technology and Intelligent Operations centers. The company’s workforce of 699,000 professionals is dedicated to harnessing technology and human ingenuity to deliver innovative solutions to clients in more than 120 countries.

Job Posting: Pharmacovigilance Services Analyst

Roles and Responsibilities

Preparation and Review:

  • Prepare and review Periodic Safety Update Reports (PSURs) following Client Standard Operating Procedures (SOPs) and Work Instructions.

Coordination and Communication:

  • Identify and coordinate with contributors; if unavailable, contact the Brand Safety Leader (BSL).
  • Organize and send kick-off meeting (KOM) invites to contributors with necessary documents like agenda, PSUR preparation guide, previous PSUR, Core Data Sheets (CDSs), reference safety information, and dial-in details.
  • Collaborate with Client Drug Regulatory Affairs to gather necessary information including brand names, generic names, country of submission, registration procedure, and any existing PSUR assessment reports.
  • Work with the Client Pharmacovigilance Data Management (PVDM) team to confirm Argus drug codes and ensure verification by Client Safety physicians before KOM.

Data Management and Reporting:

  • Ensure all drug codes and requirements for POP information/Integrated medical safety data are confirmed during the KOM.
  • Communicate with relevant stakeholders to gather necessary inputs for PSUR.
  • Inform the processing team to process relevant cases according to the PSUR schedule.
  • Oversee data cleaning processes before final listings generation and coordinate with Client safety physicians to resolve report-related queries.

Drafting and Review:

  • Lead author activities, preparing submission-ready draft reports.
  • Conduct peer reviews of draft reports, providing feedback through a defect tracker.
  • Ensure completeness and accuracy of source documentation provided by Client for PSUR/AR.

Quality Control and Submission:

  • Facilitate reviews by Novartis stakeholders, including Quality Control (QC) and Qualified Person for Pharmacovigilance (QPPV).
  • Address all comments from Client stakeholders, including QC reviewers.
  • Use Client Style to ensure consistency in formatting before submission.
  • Escalate any delayed inputs promptly.
  • Archive all PSUR-related information in dedicated folders on Novartis Shared Drives.
  • Upload the final PSUR in the Document Management System (CREDI) for publishing, and ensure TASL approval.
  • Notify PSUR Mail-box to initiate the publishing of the final report in CREDI and update the PSUR tracker in I-drive for all Key Performance Indicators (KPIs).

Additional Information

  • Experience: 3 to 5 years
  • Qualification: Any Graduation
  • Location: Bengaluru
  • Industry Type: Pharma / Healthcare / Clinical Research
  • Skills Required: Pharmacovigilance Services – Pharmacovigilance & Drug Safety Surveillance
  • Functional Area: Pharmacovigilance
  • End Date: 30th June, 2024

Join us to leverage your expertise in pharmacovigilance and contribute to our mission of ensuring drug safety and compliance. Apply now to be a part of our dynamic team in Bengaluru!

To apply for this job please visit www.accenture.com.