We are hiring a Quality Reviewer – Pharmacovigilance to ensure compliance and accuracy in case processing within the Argus Safety Database. The ideal candidate will have strong expertise in ICSR (Individual Case Safety Report) processing and Clinical Trial case handling.
Key Responsibilities:
- Conduct quality reviews of pharmacovigilance cases in the Argus Safety Database.
- Ensure compliance with global pharmacovigilance regulations (GVP, ICH-GCP, FDA, EMA).
- Perform data accuracy checks for ICSRs and clinical trial cases.
- Identify and resolve discrepancies in case processing.
- Maintain SOP adherence and documentation for audits.
- Collaborate with PV teams to improve case processing efficiency.
Requirements:
- Education: M.Pharm / B.Pharm / BDS / PharmD
- Experience: Minimum 2 years in Pharmacovigilance Quality Review (Argus Safety Database).
- Mandatory Skills:
- Strong knowledge of ICSR case processing
- Experience with Clinical Trial case handling
- Proficiency in Argus Safety Database
- Understanding of MedDRA and WHO-DD coding
- Preferred: Experience in regulatory compliance and audits.
About Soterius
Soterius is a leading name in pharmacovigilance and drug safety services, providing end-to-end solutions for pharmaceutical companies. With a strong focus on compliance and quality, Soterius ensures adherence to global pharmacovigilance standards.
How to Apply
Interested candidates meeting the criteria can send their updated resume to:
Email: himank.verma@soterius.com
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Note: Only shortlisted candidates will be contacted for further interviews.
