1.0 - 3.0 years

5 - 9 Lacs

mumbai, ahmedabad, gurugram

Work from Office

Detailed Job Role: Monitor and document drug safety data, perform adverse event reporting, assist with pharmacovigilance and risk management. KRA (Key Responsibility Areas): Case assessment, adverse event documentation, timely reporting, risk communication KPI (Key Performance Indicators): Event processing time, report accuracy, submission regularity, follow-up efficiency Job description: Job Summary:We are seeking a meticulous Drug Safety Associate to monitor, document, and manage drug safety data while supporting pharmacovigilance and risk management activities. The ideal candidate will ensure timely and accurate reporting of adverse events, contributing to patient safety and regulatory compliance. Key Responsibilities: Monitor, collect, and document adverse event data from clinical trials or post-marketing sources Perform case assessments and determine seriousness, causality, and expectedness of adverse events Prepare and submit timely safety reports to regulatory authorities Assist in pharmacovigilance activities, including risk management plans and safety signal detection Communicate safety information to relevant stakeholders and follow up on outstanding cases Maintain compliance with local and international regulatory requirements (GVP, ICH-GCP) Key Performance Indicators (KPIs): Timeliness of case processing and report submissions Accuracy and completeness of adverse event documentation Regularity and compliance of regulatory submissions Efficiency of follow-ups on safety cases Skills & Competencies: Strong knowledge of pharmacovigilance guidelines and regulations (GVP, ICH, FDA, EMA) Attention to detail and analytical skills Effective communication and documentation skills Ability to manage multiple cases simultaneously Proficiency in safety databases (eg, Argus, ARISg) and MS Office )

Posted 1 week ago

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