Job Title: Signal Management Quality Review Specialist
Location: [Not specified]
Company: Vizen Life Sciences Pvt. Ltd.
Job Type: Full-Time
About the Company:
Vizen Life Sciences Pvt. Ltd. is a leading provider of pharmacovigilance and life sciences services. We are committed to advancing drug safety through excellence in compliance, data-driven insights, and global regulatory alignment.
Role Overview:
We are seeking an experienced professional with 4–5 years of hands-on expertise in Signal Management. The role involves advanced safety signal detection, medical evaluation of safety data, regulatory database management, and cross-functional collaboration to ensure the highest safety standards for marketed products.
Key Responsibilities:
Safety Signal Detection & Triage: Perform detection and triage of safety signals using post-marketing spontaneous reporting databases; analyze both individual cases and aggregate data.
Expert Evaluation: Provide expert assessment of safety signal detection outcomes in Safety Review Meetings and Joint Safety Committees.
Collaboration: Work closely with product safety leads as a core member of the Signal Management Team.
Database Analysis: Conduct searches in Health Authority databases (FAERS, Vigibase, iDAP, DAEN); perform QC checks of colleagues’ searches.
EudraVigilance Management: Handle requests and monitor assigned products within the EudraVigilance system.
Mentoring & Training: Support the development and mentoring of junior signal management colleagues.
Guidance & SOP Development: Contribute to drafting, updating, and refining SOPs and Business Guidance documents.
Innovation: Support the development of new approaches for automated signal detection using internal and external databases.
Qualifications:
Bachelor’s degree in a relevant scientific/medical field (Pharmacology, Medicine, Life Sciences); advanced degree preferred.
4–5 years of direct experience in pharmacovigilance signal management (mandatory).
Strong expertise with post-marketing safety databases (FAERS, Vigibase, iDAP, DAEN).
Hands-on experience with EudraVigilance requests and QC of database searches.
Strong analytical, organizational, and problem-solving skills.
Excellent communication and cross-functional collaboration abilities.
Experience developing SOPs and business process documents.
Why Join Us?
This is a unique opportunity to apply your signal management expertise in a challenging and dynamic environment. You’ll work with cross-functional experts, mentor colleagues, and contribute to innovation in automated signal detection—driving patient safety at a global level.
Estimated Salary: ₹14 – 22 LPA (based on market benchmarks for mid-senior signal management roles in India).
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