Patient Safety Associate

Wilmington, DE

Posted: 07/20/2022 Job Number: 21188759

Job Description

PATIENT SAFETY ASSOCIATE
WILMINGTON, DE
Onsite position.

Required Skills:
  • Qualified to degree level in biosciences preferred 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 US FDA and international regulatory requirements for single case expedited reporting and periodic updates.
  • Demonstrable communication skills.
  • Maintains high ethical standards, including a commitment to Client's values and behaviors.
  • Good attention to detail.
  • Good time management.
  • Fluent in English.
  • Computer literate.
  • Professional qualification.
  • Project Management experience.

Project Description:
  • Provides accurate and timely US regulatory submissions preparation and submission of reports meeting US FDA expedited reporting criteria to the FDA, including requesting literature articles.
  • Prepares and ensures accurate regulatory submissions of IND cross-reporting SUSARs to FDA.
  • Prepares the US Investigator Safety Letters to the ISL Administration group for onward distribution to the US Investigators.
  • Ensures monthly reconciliation of AE data exchanged between US vendors and for the US Licensing Agreements.
  • Manages the US Patient Safety mailbox for AE reports and queries.
  • Individual in this role carries out a range of activities and processes to provide support to the US Medical Affairs Patient Safety business unit that are both routine and very specific depending on the query.
  • This role impacts the reputation of the function it serves as the initial point of contact for many customers.
  • 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.
  • Maintain knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
  • Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including expedited and periodic safety reporting.
  • Coordinates and prepares the prompt submission of expedited reports, including preparing cross reporting submissions, to the Regulatory Submissions Department in order to comply with the FDA reporting timeframe.
  • Coordinates and prepares the prompt submission of Investigator Safety Letters to the Clinical ISL Submission group in order to comply with FDA reporting timelines.
  • Maintain local internal compliance and external reporting schedules for reports sent to the FDA and Investigators.
  • Construct, process and submit follow-up letters to consumers, and health care professionals and request clarification from foreign affiliates according to specific report types using both global and local SOP timeframes.
  • Perform activities required for exchanging safety data with licensing partners to maintain regulatory compliance in consultation with the Patient Safety Operations Specialists.
  • Perform reconciliation of adverse event data exchanged with vendors and license partners.
  • Maintain accurate tracking system for all AE reports.
  • Acts as the Regional system administrator for the Global Learning Management System.
  • 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 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.
  • Conduct application training in both classroom setting and individualized setting
  • 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.
  • Demonstrated ability to perform with minimal supervision.

This 4+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindi@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02216
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Cindi Pisnoy

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