Site Activation Coordinator -Turkish Speaker.
Under moderate supervision, executes the safety submisisons with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages submission documentation; reviews and negotiates safety reports documents and submissions with global safety teams and sponsors; maintains, reviews, and reports safety submission performance metrics; serves as the primary point of contact for both local and the foreign safety submissions.
Responsibilities for this role are as follows:
Assists with the design, preparation and assembly of the expedited and periodic safety report documents
• Maintains tracking of safety submissions
• Fosters constructive and professional working relationships with all project team members, internal and external
• Applies safety reporting regulatory intelligence maintained by IQVIA to all safety reporting activities
• Files documents according to project specific requirements (electronically or in hard copy as applicable)
• Forwards completed safety submission documents to clients and other relevant parties
• Provides support with miscellaneous project tasks related to safety reporting
• Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process
The ideal candidate will need the following experience / skills to be considered:
• Bachelor’s Degree in life science, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
• Safety and Pharmacovigilance experience preferred
• Safety Database systems and moderate medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
• Ability to work independently and in a team environment
• Ability to successfully prioritize and work on multiple tasks
• Excellent communication and interpersonal skills, both written and spoken
• Strong organizational and documentation skills
• Detailed oriented with a high degree of accuracy and ability to meet deadlines
• Good knowledge of ICH guidelines and regulations relating to Safety and Pharmacovigilance
• Able to make effective decisions
• Manage multiple priorities
.Turkish native language proficiency
.Turkish and English reading and writing skills.
.Proficiency in speaking fluent Turkish and English.
.Turkish citizenship is preferred.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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