Pharmacovigilance Services Sr Lead Analyst

2 weeks ago

Bengaluru, Karnataka, India Lifelancer Full time

Company Overview: Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the world's largest network of Advanced Technology and Intelligent Operations centers.

Job Description: In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.

Estimated Salary Range: $80,000 - $120,000 per year, based on industry standards and location. This salary range may vary depending on individual qualifications and experience.

About Lifelancer: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Roles and Responsibilities:

  • Prepare and review PSURs as per the Client Standard Operating Procedures and Work Instructions.
  • Identify contributors based on the contact list if the same is not available, contact Brand Safety Leader (BSL).
  • Liaise with Client Drug Regulatory Affairs team and request brand names generic names, country of submission, registration procedure, HA PSUR assessment report (if any), and CDS for reference.
  • Liaise with Client Pharmacovigilance Data Management (PVDM) team to provide the Argus drug codes and get it confirmed by Client Safety physicians before KOM.
  • Ensure the confirmation of drug codes is addressed during the KOM.
  • Ensure the confirmation on the requirement for POP information/Integrated medical safety data from BSL during the KOM.
  • Liaise with relevant stakeholders for the inputs required for the PSUR.
  • Notify the processing team to process relevant cases as per the PSUR schedule.
  • Capture quality data for metrics reporting.
  • Facilitate Novartis stakeholders review including QC QPPV review.
  • Shall address all the comments received from all the Client stakeholders including QC reviewer.
  • Use Client Style and ensure consistency in formatting before submission.
  • Ensure the consistency, On-time escalation of any delayed inputs.
  • Archival of all the PSUR related information in dedicated folders on Client Shared Drives.
  • Upload final PBRER in Document management system (CREDI) for publishing and ensure that the TASL approves the PBRER.
  • Email PSUR Mail-box for initiating publishing of the final report in CREDI as soon as approved by TASL in CREDI, Update PSUR tracker in I-drive for all KPIs.

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