DirecciónAt AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
The Senior Patient Safety Specialist contributes to the core components of the local pharmacovigilance system, thus ensuring AZ has in place an effective pharmacovigilance system that aligns with the local PV requirements.
Typical Accountabilities
Leading Patient safety activities related to the processing and handling of Individual Case Safety Reports (ICSRs), and follow-up cases, received from clinical and post-marketed sources for AstraZeneca products in addition to conducting Monthly quality control processes.
Ensure timely submission of ICSR, follow-up cases, and other safety documents (PBRERs, DSURs, Signals, SUSARs, RMPs, DHPCs, etc) to local health authorities.
Annual update and testing of local Business Continuity Process (BCP)
Support delivery of PS training to local staff and locally engaged vendors including annual refresher training.
Handle Health Authority interactions and queries, such as for ICSR-related products, related safety concerns, and educational materials associated with the Risk Management Plan (RMP)
Ensures corrective and preventative actions are taken in the event of local non-compliance.
Essential skills and Qualifications
- Bachelor’s degree or equivalent experience experience in science/healthcare related field or validated Patient Safety experience
- Demonstrated knowledge of domestic and global regulations relevant to patient safety
- Excellent understanding of pharmacology, including drug interactions
- Ability to comprehend and analyze pharmaceutical literature
Be welcomed into our diverse community, where every voice is important, and we’re united by a local sense of belonging. Because, unlike others, we have a decentralised model that gives us ownership at a local level. We tailor how we work, adapting to our markets and healthcare systems.
