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Pv safety scientist
Job Description
Pv safety scientist
Job Summary
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Location: Sofia
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Project role: Pv safety scientist
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Qualification: B-Tech, Medical Science
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Experience: 0-3 Years
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Skills: Adverse Event
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No. of positions: 1
Job description:
Safety scientist performs case processing for clinical trials and post-marketing cases.
- To partner with Program Manager in communicating key issues and milestones to the stakeholders, and ensure that all internal and client-specific activities are performed in compliance with regulatory requirements.
- To perform literature review for identification of case reports and relevant safety information, prepare training materials specific to safety and mentor and train neworexisting staff on client requirements.
- To process and evaluate AE reports according to the customer's standard operating procedures (SOPs), ensure quality and accuracy of data and assist in the reconciliation of clinical and safety databases.
- To assist with the preparation of adverse event reporting plans (AERPs), participate in quality assessment reviews, audits and engage in gap analysis for SOPs
- To be responsible for quality levels and revision rates of client to include all aspects of client revisions including running reports, completingorassigning revisions, compiling data, developing strategies to reduce revisions, mentoring staff on revisions, and communicating revision information to the client.
Why Join Us:
At HCL Technologies, we promise many varied opportunities for you to learn, along with the potential to do innovative, interesting work, and to fast track your career. You will have access to the Global clients and team from some of the most experienced leaders in the tech industry who will enable you to get on the fast track to a rewarding tech career. HCL Technologies offers the leadership, flexibility, and people-friendly work culture to enrich the life of an employee and of those around them - to find greater stability, purpose, and growth both personally and professionally.
We encourage our people to try things differently, provide them with the freedom to explore, opportunities to grown, and experiment while offering intensive training and on-the-job coaching opportunities. Our people take pride in their enthusiasm and commitment to go beyond. And we celebrate this collective pride. Below are few of the benefits and perks:
- Global careers and mobility
- A flexible (remote) working environment with work-life balance
- Great opportunities to make the role your own, upskill yourself and get involved with exciting projects
- Total Wellbeing is our focus. Alongside your professional excellence, you join the likeminded colleagues to create a larger impact within the company and society at large in your chosen area of passion - CSR Council, Diversity Council, Sparks – Engagement Champion to name a few