Pharmaceutical Case Management Quality Assurance Specialist

1 week ago


Mumbai, Maharashtra, India Lifelancer Full time
About the Role

We are seeking a skilled Pharmaceutical Case Management Quality Assurance Specialist to join our team at Lifelancer. This is a full-time position that requires a strong background in pharmacovigilance and quality assurance.

Job Overview

The successful candidate will be responsible for maintaining and performing necessary processes to ensure high-quality and compliant reporting of individual case safety reports in accordance with PV regulations. They will monitor the quality of individual case reporting to ensure internal and regulatory compliance.

Key Responsibilities
  • Perform retrospective quality review of different types of case reports such as Post Marketing Surveillance (PMS), Hospital discharge summaries, Spontaneous and Literature reports processed.
  • To check accuracy all data entered in OARS including coding of adverse event reports, Narrative, labeling and causality, Relatedness/Expectedness assessment in compliance with SOPs and regulatory requirements.
  • Participate in team meeting, training of the team, and contribute towards process and quality improvement, and compliance, and process harmonization.
  • Preparing sharing quality reports with operational team on a regular basis, contribution in RCA/CAPA of quality nonconformance.
  • Partner with internal and external stakeholders to identify, prioritize and monitor quality and compliance issues and develop solutions to minimize risk and ensure the overall quality management system.
Requirements
  • Bachelors degree or masters degree in a life science/health care/pharmaceutical related field.
  • Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities related to individual case safety reporting.
  • Previous experience with Pharmacovigilance and PV system (preferably Argus) and quality review activities.
Benefits

We offer a competitive annualized salary range of $80,000 - $110,000 depending on location, flexible work arrangements, and opportunities for professional growth and development.

About Us

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.



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