About the Client:

Client is a global Fortune 500 IT solutions company specializing in delivering simple and scalable solutions to address complex business problems. More than 1,500 staff delivers technical and domain expertise across multiple platforms and industries to help enterprise companies drive productivity, efficiency and gain the most out of their technology investments.

Designation: Pharmacovigilance – Case Processing Associate

Join our growing Pharmacovigilance team! We're looking for experienced professionals with expertise in ICSR Case Processing and Quality Review.

Open Positions

SPE – ICSR / Pharmacovigilance

Experience: 1–4 Years
Function: Pharmacovigilance / ICSR Case Processing

Key Responsibilities:

Manage end-to-end ICSR case processing, including intake, triage, data entry, follow-up and case closure.
Perform MedDRA/WHO Drug coding, narrative writing and case assessment as per SOPs and regulatory requirements.
Ensure accurate and timely processing/submission of serious and non-serious ICSRs within defined timelines.
Maintain high standards of data quality, compliance and documentation across the case lifecycle.
Support reconciliation, quality checks and resolution of case-related queries or discrepancies.

Required Skills:

1–4 years of relevant Pharmacovigilance / Drug Safety / ICSR experience.
Hands-on experience in ICSR case processing.
Strong understanding of PV processes, regulatory timelines and safety case lifecycle.
Argus and/or Veeva Safety experience preferred.
Graduate/Postgraduate in Pharmacy, Life Sciences, Medical Sciences or a related discipline.

Requirements

Relevant educational background and experience in patient safety or related field
Strong presentation and communication skills
Effective intercultural work capabilities
Commitment to timely completion of tasks and documentation
Analytical and problem-solving skills
Collaboration and teamwork abilities

Joining Preference: Immediate to 30 Days highly preferred. 90-day notice period candidates will not be considered.

Habilidades requeridas

ICSR end-to-end case processingMedDRA codingWHO Drug Dictionary codingNarrative writing for ICSRsCase assessment and seriousness determinationPharmacovigilance processes and regulatory timelinesArgus safety database experienceVeeva Safety case management experienceData quality, documentation and compliance in PVCase reconciliation and discrepancy resolutionAnalytical and problem-solving skillsCommunication and presentation skillsCross-cultural collaboration and teamwork

Empleos similares