AstraZeneca Pharmaceuticals LP Senior Patient Safety Specialist - Compliance in Wilmington, Delaware
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Senior Patient Safety Specialist, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
As a member of the Section’s Compliance team 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.
The Senior Patient SafetySpecialist assigned to the Compliance team, in addition (as appropriate), also:
Provides oversight of local and global (as required) compliance data for adverse event reporting.
Leads the analysis and trending of compliance data and communicates to customers monthly or more frequently as required.
Leads the monitoring of compliance with local and global procedural documents, licensing agreements and regulations.
Leads in-depth quality reviews of data, reports and regulatory submissions.
Drives and implements guidance on inspection preparedness.
Manages, supports, and optimizes the compliance safety meetings process for the region.
Leads the management of the generation and maintenance of local Safety data exchange agreements (SDEAs) and directing modifications as driven by internal or external requirements of existing agreements.
Acts as the pivotal point of contact for the preparation and/or revision of SDEAs or pharmacovigilance language between the US Patient Safety function and other involved functions, including Legal, Medical Information, Regulatory, Quality Assurance and Commercial, etc.
Liaises as necessary with licensing partners for agreement on compliance questions and issues.
Leads the maintenance of a tracking system of SDEAs, in relation to existing Licensing Partner Agreements, including required review dates and dates of renewal.
Collaborates with the team leader(s) to establish/maintain performance metrics for quality and submission timelines pertinent to SDEAs.
Leads the assessment of the compliance aspects of safety data exchange agreements, for example by monitoring the timeliness of submissions and trending of compliance data. Carries out root cause analyses for reports that are late to regulatory authorities and/or licensing partners.
Alerts senior management of any possible deficiencies in quality and compliance standards related to SDEAs and work with internal staff and external vendor and business partners to agree on corrective and preventative action.
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, GVP, 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.
Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background
4-8 years of Pharmacovigilance experience to include knowledge of pharmacovigilance practices, (including Safety Data Exchange Agreements, and/or Pharmacovigilance auditing), 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
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 Safety Data Exchange Agreements, and/or Pharmacovigilance auditing,or compliance, audit/regulatory inspection 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
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.