Patient Safety Associate - Support Job

Company Name:
Patient Safety Associate - Support
Patient Safety Associate - Support needed for a contract opportunity with Yoh's client located in Wilmington, DE. The Big Picture - Top Skills You Should Possess: - Patient Safety - Compliance What You'll Be Doing: - Perform all activities within the required timeframes to ensure compliance - Maintain well-documented files for process reviews and issue investigations - Support a performance-driven culture - Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures - Coordinates the timely collection of reasons for late reporting and corrective actions to prevent future late reporting from clinical, regulatory and marketing for inclusion in safety reports to regulatory authorities - Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting - Support regulatory inspections and internal audits - Executes special database queries to prepare additional reports required by FDA for inclusion in US periodic safety report submissions, and coordinate with other Regional Patient Drug Safety groups to ensure that all PSUR-related documents are acceptable for submissions to FDA - Review safety data output for accuracy and completeness prior to submission to internal and external sources - Provide scientific and technical contribution to the maintenance of one or more of the Support Section activities within the Region - Contribute to the implementation of new safety-related systems, processes and procedures within the Region - Have effective project-management skills, including the ability to manage multiple competing tasks - Participates in cross-functional project team meetings to provide guidance to contributors of documents for submission to regulatory authorities - Demonstrate ability to effectively coordinate cross-functional projects and manage timelines - Maintain local internal compliance and external reporting schedules What You Need to Bring to the Table: - Qualified to degree level in biosciences or an appropriate healthcare or pharmaceutical industry background - Basic competence with medical and therapeutic terminology - Able to work independently, guided by procedures, with appropriate support - Able to work effectively as part of a team - An understanding of the international regulatory requirements for single case expedited reporting and periodic updates - Demonstrable communication skills - Maintains high ethical standards, including a commitment to Company values and behaviors - Good attention to detail - Good time management -
literate Opportunity is Calling, Apply Now! Recruiter: Hannah Cihlar Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. J2W: SCIENTIFIC; J2W: PROF J2W: CLINICAL MONJOBJ2WMIDATL Ref: SFSF: LS MYK62683JR

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