Assoc Princ Specialist PS Enablement

AstraZeneca is now seeking an Assoc Princ Specialist PS Enablement, with the location Gothenburg!

Do you have knowledge in regulatory/pharmacovigilance and partnership issues ? Do you have a “can do” attitude and an innovative approach and want to contribute to ensure good relationships across Patient Safety and related functions within Astra Zeneca and Alexion? Then this unique role with a broad spectrum of responsibilities might be the one for you!

Purpose, Offer and Benefits

At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Ensuring AstraZeneca comply with Pharmacovigilance regulations is key and in our team we make sure to make this a reality.

Here you will have a great opportunity to use your deep understanding of regulatory and pharmacovigilance processes and regulations providing process or compliance support to safety and regulatory teams and submissions as well as to develop and maintain a vision and strategy for nominated pharmacovigilance or regulatory processes.

Your Responsibilities

As an Associate Director you will be working with Directors and Associate Directors in PV Processes, Partnerships and Contracts area, taking responsibility for the management of ICSR process and vendor oversight in AstraZeneca/Alexion, covering processes and partnerships including implementation, communication, compliance, performance and inspection readiness. In addition you will:

• Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment
• Working with the PV Process, Partnership and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting
• Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy
• Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca´s pharmacovigilance and regulatory LTO responsibilities
• Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment
• Working with the PV Process, Partnership and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
• Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
• Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca´s pharmacovigilance and regulatory LTO responsibilities.
• Provide support and oversight to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection

The Bigger Picture

Global Patient Safety Process & Partnership team is responsible for the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, compliance, performance, vendor oversight and inspection readiness within the ICSR area. We ensure good relationships across Patient Safety in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.

This is a 1 year assignment (with a chance of extension). You will be employed by TNG during this time.

Please note that the selection process is ongoing!

Our Expectations

Essential for the role:

• A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Experience in working cross-functionally
• 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

Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organisational goals!