To partner with other Clinical Operations and Patient Safety Process Owners and be a subject matter expert for all aspects of the Safety Reporting processes for which Clinical Operations personnel are either accountable or responsible, in the end-to-end clinical trial process (from study design through to study closure).

Scope includes:

• Site Management and Monitoring responsibilities, including ISF requirements
• Study Management responsibilities, including VCV data entry and oversight, late case management
• Data Management responsibilities, including system set-up requirements and SAE reconciliation, email alert set-up, late case management
• Centralized Services such as PSLL, SUSAR and ISL Reporting and Distribution

Key Responsibilities:  

• Act as the primary point for contact for audits and inspections in Safety Reporting area
• Partner with Patient Safety Process Owners to develop and maintain procedural information and training to ensure Clinical Operations personnel understand and deliver all of the expected requirements to time, cost and quality
• To be a single point of contact for Clinical Operations and External Service Provider personnel with respect to Clinical Operations specific safety reporting process questions and issues
• Contribute to the resolution of any quality issues reported relating to Clinical Operations safety reporting activities. Investigate the root causes of issues and input to or own Corrective and Preventative Actions (CAPAs) relating to Clinical Operations activities as required
• Provide input to and coordinate requests for evaluation of new guidelines and regulations related to safety reporting. Ensure the review of procedural documents also include reviewers from other impacted process areas, approvers as well as training requirements, if applicable
• Identify, drive and implement improvements as required
• Liaise with relevant System Owner(s) to ensure that processes, procedures and systems are aligned
• Provide business support and training of owned processes as required
• Cooperate with Patient Safety Global Compliance to monitor performance and KPI’s related to Safety Reporting
• Act as Safety SME for AZ outsourced delivery models

Essential: 

• A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Experience in working cross-functionally
• Proven experience in inspections and audits
• Leadership skills, including proven leadership of project teams experience
• Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues 
• Thorough knowledge of the drug development process
• Good attention to detail
• Excellent written and verbal communication skills

Desirable

• Knowledge of AZ Business and processes
• Able to influence whilst maintaining independent and objective view,
• Strong collaboration and vendor management skills
• Relationship builder
• Able to work effectively as a member of a cross-functional or global team
• Understanding of change management process
• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.