9.0 - 13.0 years

0 Lacs

hyderabad, telangana

On-site

The PV Scientist Manager is responsible for contributing to the planning, preparation, writing, and review of non-medical portions of aggregate reports. Collaborating with affiliates and other internal Amgen partners, the PV Scientist Manager ensures timely deliverables. Additionally, reviewing Adverse Events/Serious Adverse Events from clinical trials is part of the role. Under the guidance of the Global PV Sr. Scientist or Lead, the PV Scientist Manager reviews study protocols, statistical analysis plans, and other clinical study-related documents. They provide input on the design of safety data tables, figures, and listings from clinical studies. Participation in the development of safety-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

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