Senior Specialist, Patient Safety

AstraZeneca is a science-led, global biopharmaceutical company, committed to improving the health and lives of people across the globe through our research and development platform and a growing late-stage pipeline. With a presence in over 100 countries, we have strength in emerging markets, and our medicines are used by millions of patients and clinicians worldwide. Working here means being results-oriented and working together to make the impossible a reality.

Patient Safety Global Markets currently have an exciting opportunity for an experienced Senior Patient Safety Specialist to join our established Global Patient Safety Global Markets function who are responsible for the management of Pharmacovigilance activities in AstraZeneca and Alexion’s Local Marketing Companies.

What’ll you do?

Working closely with cross-functional stakeholders across the AstraZeneca and Alexion UK, Ireland and Malta marketing companies, as well as Global Patient Safety functions, you will be contributing to the core components of Pharmacovigilance systems by:

• Managing day-to-day Pharmacovigilance operations via management of Pharmacovigilance activities, databases, projects, procedures and services in line with local health authority regulations
• Embedding yourself with other GxP stakeholders such as GRP and GCP, forming an enterprise to maintain upmost compliance
• Ensuring cross-function collaboration through sharing Patient Safety knowledge and training with the local marketing company teams (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs)
• Providing technical guidance and contribution to local and global projects aligned to or involving Patient Safety
• Facilitating the necessary quality requirements, including the provision and submission of Pharmacovigilance data to Global Patient Safety and local health authorities
• Ensuring timely submission of ICSR, follow-up cases, and other safety documents (PBRERs, DSURs, Signals, SUSARs, RMPs, DHPCs, etc) to local health authorities
• Acting per local legislation requirements as a deputy Patient Safety Contact Point/LRPPV (or deputy) with the local health authority to manage Individual Case Safety Report (ICSR) related queries, AstraZeneca and Alexion product-related safety concerns, or activities related to Risk Management Plans (RMPs).

Essential criteria:

• Understanding of local UK, Ireland and Malta health authority regulations
• Experience in internal audits / external health authority inspections
• Experience in using Pharmacovigilance systems such as Argus and Veeva Vault modules
• Experience in Pharmacovigilance vendor management
• Excellent attention to detail, project management, problem solving, written and communication, and change management skills
• Strong data analytics abilities

Desirable criteria:

• Knowledge of and experience in local Marketing Companies including established cross-functional stakeholder relationships
• Medical knowledge in AstraZeneca and Alexion business units and therapy areas
• Leadership skills
• Proven track record on above-market Patient Safety projects

So, What’s Next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

We encourage you to apply online!