This is what you will do:

This position has primary responsibility for ensuring oversight of the global case processing vendor who is engaged in  the collection, follow-up, onward transmission of domestic cases within Alexion Germany and shall take care that those processes are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in  accordance with any PV agreements with third party business partners.

Within the assigned geographic area, the Associate Director, Patient Safety is responsible for appropriate local PV system oversight, including any elements of the PV system that are contracted to a third party. This includes responsibility for ensuring the processes and systems necessary for the Associate Director, Patient Safety to fulfil their responsibilities, both internal and outsourced, comply with global and local requirements: remain current with applicable regulations: and are followed consistently, by ensuring delivery of any training necessary. The Associate Director, Patient Safety tracks system performance including regulatory compliance and provides periodic reports to management.

The Associate Director, Patient Safety reports into the Cluster Lead Alpine AstraZeneca.

You will be responsible for:

• Oversight of case processing vendor who is engaged in the collection, translation, entering of initial/follow-up AE information into the safety database including follow-up activities, as appropriate, that originates from any relevant PV data source, and onward forwarding of the AE information to vendor if received locally.
• Oversight of Literature Screening activities by global vendor and annual review of journals
• Regulatory Intelligence
• PV routes testing
• Reconciliation activities as applicable
• Digital Assets review and oversight
• Oversight of PV-relevant third-party vendors including developing and maintaining effective business relationships and tracking performance metrics including regulatory compliance
• Act as primary contact for Global Patient Safety and local staff in the countries of responsibility when needed
• Executes CAPA plans and oversees the development implementation as needed
• Provision of PV expertise, review and safety approval to Organized Data Collection activities such as Market Research Programs, Patient Support Programs, non-interventional studies incl. oversight of the vendors and review of contracts
• Tracking of performance including regulatory compliance and provision of periodic metric reports to General management and Global Safety
• Review and approval of late cases reported late to GPS
• Provide PV-training to local country staff and related contractors/vendors as applicable
• Local PV system oversight including any elements of the PV system that are contracted to a third party, ensuring inspection-readiness at all times.
• Local aRMM implementation, relevant associated documents and metrics maintenance and lead of the Local aRMM implementation team in the country as applicable
• Represents GPS during local Pharmacovigilance audits and inspections
• Other PV related tasks may be requested on demand

Qualifications

• University degree in medicine, pharmacy, natural sciences
• Extensive experience in pharmaceutical industry or equivalent with majority in a PV functional role (minimum 4 years)
• Fluent in German and English language required
• The candidate should be a self-starter, with a desire to be part of an open and collaborative team.
• The candidate should demonstrate ability to quickly assimilate new information and translate into actionable strategies and activities
• Ability to manage multiple projects simultaneously and well-developed prioritization skills are strong asset
• Ability to build team relationship and collaborate in a global team environment at all level of the organization
• Strong interpersonal communication
• Understand the origin and reasoning behind key policies, practices and procedures
• Can anticipate challenges and take timely and pro-active action

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.