Senior Safety Writer and Project Coordinator Fortrea

4.0 - 8.0 years

0 Lacs

pune, maharashtra

On-site

Role Overview: You will lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Your responsibilities include end-to-end report management, planning, authoring, managing review and submission steps, applying safety domain knowledge, managing deliverables of medium to high complexity, and ensuring timely delivery of high-quality documents to internal customers and sponsors/clients. You will coordinate activities related to several types of report writing across a team of writers, perform support activities such as tracking, maintenance of metrics, quality checks, and training, and assist Medical Writers in preparing safety r...

Posted 1 week ago

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Global Safety Associate Medical Director Amgen

8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

As the Global Safety Officer (GSO) for Marketed Products, your primary role is to ensure the safety and well-being of the assigned marketed products. You will be responsible for establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. Your accountability extends to overseeing the overall safety profile, making product-related decisions, and delivering on all associated responsibilities. Key Responsibilities: - Developing and maintaining core reference safety information - Conducting benefit-risk evaluations - Participating in the product label process - Developing strategies for clinical trial safety - Leading responses to safety-...

Posted 1 month ago

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Safety Writer Fortrea

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. You will perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussions for comment resolution. Additionally, you will write various safety ...

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