Senior Safety Specialist

vor 1 Monat


Hobart, Österreich Tideri Jobbörse Vollzeit

Job Title: Senior Safety SpecialistJoin Syneos Health, a leading biopharmaceutical solutions organization, as a Senior Safety Specialist.
In this role, you will be responsible for developing and maintaining a repository of relevant documents, facilitating SPVG Annual Revenue targets, and providing SPVG metrics as appropriate.
Key Responsibilities:Develops and maintains a repository of all relevant documents (e.g., Training, Safety and Pharmacovigilance Project Finance, Proposals tracking [awards and losses], RFI Library, departmental metrics, lists of audits/inspections).Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.Facilitates SPVG Annual Revenue targets by working with the operational SPVG team members and Therapeutic BU PMs / Project Directors, to ensure accurate and timely recognition of the BU in RBB.Provides SPVG metrics as appropriate at agreed upon intervals based on assigned tasks.Performs other work-related duties as assigned.Requirements:Bachelor's degree in life science, registered nurse, pharmacist, computer science or technology related field (technical role) or equivalent combination of education and experience.Safety Database systems and moderate medical terminology required.Extensive clinical research work, data collection/computer systems or equivalent experience including understanding and application of principles, concepts, practices, and standards in the pharmaceutical or CRO industry preferred (technical role).Excellent computer skills and knowledge of relational databases.
Oracle Insight/Analytics/Data Mart, and Crystal Reports/Business Objects, SQL Plus experience preferred (technical role).Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.Ability to work independently and in a team environment.Ability to successfully prioritize and work on multiple tasks and projects.Excellent communication, presentation, interpersonal skills, both written and spoken.Strong organizational and documentation skills.Detail oriented with a high degree of accuracy and ability to meet deadlines.Able to make effective decisions.Manage multiple priorities.Minimal travel may be required.About Syneos Health:Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.



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