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

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!

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