The 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 with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Vacancy Details :
- Position Name : Safety Science Analyst
- Organization : Fortrea
- Qualification: B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
- Experience: 0 YEARS / Freshers
- Salary: 25,000 – 35,000 /month
- Location: Pune
Description
Adverse Event Reporting:
- Monitored, collected, and evaluated adverse event reports from clinical trials and post-marketing sources, ensuring timely and accurate submission to regulatory authorities.
- Conducted thorough case assessments, including causality assessment and medical evaluation, to ensure compliance with pharmacovigilance regulations.
Regulatory Compliance:
- Ensured adherence to global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH) through diligent monitoring and reporting practices.
- Prepared and submitted periodic safety update reports (PSURs), risk management plans (RMPs), and other regulatory documents as required.
Safety Data Analysis and Reporting:
- Analyzed safety data from various sources, including clinical trials, spontaneous reports, and literature, to identify trends and patterns.
- Prepared comprehensive safety reports and presentations for internal and external stakeholders, including safety committees and regulatory authorities.
Pharmacovigilance Systems and Tools:
- Utilized pharmacovigilance databases (e.g., Argus, ARISg, VigiFlow) to manage and track adverse event reports and safety information.
- Implemented and maintained pharmacovigilance systems and processes, ensuring data integrity and operational efficiency.
![[Freshers-2024] Fortrea Hiring in Pharmacovigilance in Pune](https://rxhirepro.com/wp-content/uploads/2024/06/FORTRREA-1024x544.png)
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