Sr Patient Safety Specialist
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Wilmington, DE 19806
As a member of the Section’s Business Support, Compliance Excellence or Information Services Team(s) is primarily responsible for coordinating the lifecycle management of pharmacovigilance processes and technology. Develops reporting tools and analysis processes and technology to identify improvements. Ensures business continuity for pharmacovigilance processes and systems. Delivers a centrally managed provision of services such as document management while meeting local regulatory requirements. Can solve complex problems within own area and will participate in research projects.
+ Conducts activities and interactions consistent with organizational values and behaviors and in compliance with the Code of Conduct and supporting policies and standards relevant to the role. Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes. Reports potential issues of non-compliance.
+ Serves as a knowledge resource to Patient Safety staff as well as to personnel in areas outside of Patient Safety with a deep understanding of organizational global and local procedural documents and local implementation of objectives, policies, processes and procedures and regulatory requirements, guidelines and obligations relevant to pharmacovigilance activities and adverse event reporting, including periodic safety reporting.
+ Leads and/or conducts a wide range of pharmacovigilance activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.
+ Leads and/or contributes to the development, improvement and validation of procedures, policies, processes, guidelines, and/or systems for the pharmacovigilance components of various activities and ensures they are compliant with AstraZeneca standards, are aligned with targeted roles, and ensures non-compliant processes are escalated.
+ Leads and/or initiates projects to increase efficiencies.
+ Leads personnel indirectly (as appropriate) within their respective area.
+ Leads and/or contributes to the scientific and/or technical contributions of new safety-related systems, processes and/or procedures within the US region.
+ Leads and/or contributes the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement.
+ Provides support to the Team Leader, or designee, in implementing various pharmacovigilance strategies, facilitating meetings and/or managing projects.
+ Provides oversight and reviews or contributes to the documentation of findings and outcomes to meet both internal and external requirements.
+ Analyses information to determine project requirements and provides recommendations/solutions.
+ Provides oversight and reviews or contributes to safety data output for accuracy and completeness prior to submission to internal and external sources.
+ Serves as a process owner for local processes with empowerment to represent the US region.
+ Leads and/or supports specific activities in regulatory inspections and internal audits.
+ Represents the US region and/or contributes to specific Patient Safety Teams.
+ Leads and/or contributes input to IS/IT teams in the development, maintenance and support of various safety systems and related applications.
+ Leads and/or contributes to the development and/or execution of user acceptance test scripts per company SOPs to confirm the functionality of Patient Safety applications.
+ Provides explanation to team leadership regarding team data, issues, trends, and action taken.
+ Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
+ Demonstrates the ability to present information to both internal and external stakeholders.
+ Conducts training in both classroom and individualized settings.
+ Trains and mentor’s junior members of the team.
+ Supports a performance-driven culture.
+ Leads or supports regional pharmacovigilance auditing activities:
+ Manages and/or assists in developing, implementing and maintaining a comprehensive risk-based pharmacovigilance compliant quality auditing program.
+ Plans, conducts, and/or assists in pharmacovigilance system audits in support of local Pharmacovigilance activities for post marketed products, external partners/vendors and licensing partners to assure compliance with the Code of Federal Regulations, GxP, ICH and AstraZeneca policies and procedures.
+ Authors, manages, and/or assists in audit reports to stakeholders and management.
+ Obtains or assists in obtaining audit responses from Pharmacovigilance and external partners/vendors and evaluates proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and AstraZeneca policies.
?Education, Qualifications, Skills and Experience
+ Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.
+ 4-8 years of Pharmacovigilance and/or Clinical Development experience, with a minimum of 4 years of pharmacovigilance department experience to include knowledge of pharmacovigilance practices, including a solid understanding of FDA and other Health Authority, and ICH regulatory requirements, guidance and obligations.
+ Proven analytical skills.
+ Proven leadership skills.
+ Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures.
+ Demonstrated ability to manage multiple competing assignments and timelines.
+ Fluent in English language with excellent communication skills, both oral and written.
+ Demonstrated ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas.
+ Demonstrated ability to influence whilst maintaining independent and objective views.
+ Demonstrates ability to maintains high ethical standards, including a commitment to organization values and behaviors.
+ Detail oriented.
+ Computer literate.
+ Advanced degree within field and/or professional certification (project management, Lean Six Sigma, ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/ Organizational Excellence, or SQA Registered Quality Assurance Professional (Minimum 3 years of PV-related Quality Assurance auditing experience).
+ Strong pharmacovigilance experience within the pharmaceutical industry and prior pharmacovigilance case handling or compliance, audit/regulatory inspection or IS/IT experience in a Patient Safety department.
+ Advanced knowledge of medical terminology, clinical terms, MedDRA, U. S. Code of Federal Regulations and global regulations regarding AE reporting.
+ Advanced knowledge of pharmacovigilance processes, standards, conventions, and governance.
+ Project management expertise.
+ Experience with process improvement initiatives.