Drug Safety Associate
Posted on: 9 Nov 2021
Peapack and Gladstone, NJ
Job Description
REQUIREMENT:
• Support the submission and distribution of reports and relevant tracking Support distribution and tracking of distribution of Follow-Up letters;
• H1B Sponsorship available
• Support inspection preparedness activities policies and practices as per Company SOPs;
• Consistently apply Archiving policies as per Company SOP.
• Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries and collection of safety data
• Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
• Working knowledge of technology required for Patient Safety
• Establishing Dossier Plans for the assigned Global submission types as needed to support the life cycle of one or more products. The candidate will be responsible for: generating dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and time lines against established KPIs.
• Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
• Support development of departmental work practices, process enhancements, and associated training materials.
• Develop/maintain associated process tools and relevant training documentation.
SynMeta
Irvine, CA
SynMeta is a pioneer technology company that helps businesses to scale-up the quality of service, achieves work efficiency, saves on time, reduces costs, TCO (Total Cost of Ownership) and sustains customer loyalty. We are a new generation company that aims to deliver innovative and cost-effective solutions for diverse industry verticals as Financial Services, Telecom, Retail, Insurance and Healthcare by leveraging on the latest technologies – proprietary and open source, SynMeta aims to provide robust Web Application Development, SAS Development, product consulting and onsite services.
SynMeta’s IT solutions portfolio aims to achieve more with less. We focus on Mobile & Web application development, Specialized in Open source technologies PHP-CMS, Life Sciences – Biostatistics, Cloud Computing, Payment Gateway Integration, Enterprise application development, Logo & Template Designing, Testing Services, Multimedia and many more with proven expertise in social networks and web analytics, our endeavors are to provide each client complete value from online presence.
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IndustryInformation Technology
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No. of Employees10-50
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Website
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Jobs Posted15
