Description
A key client of ours is seeking multiple Patient Safety Scientists, both senior and junior.Responsibilities include:
* 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
In addition, US Marketing Company Accountabilities/Responsibilities include:
* Knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting
* 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
The Senior Associate will, in addition:
* 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
Minimum Requirements -Education and Experience
* Qualified to degree level in biosciences or an appropriate healthcare or pharmaceutical industry background
* At least 2 years of prior experience within Pharmaceutical industrial dealing with patient safety
* 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 AstraZeneca values and behaviors
* Good attention to detail
* Good time management
* Fluent in English
* Computer literate
If you are interested, please send an updated resume and I will be happy to discuss the position further.
Thank you!