About the role
SUMMARY
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.
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