Manager, Senior Patient Safety Scientist

Roles & Responsibilities
• Lead safety surveillance activities for assigned products
• Perform periodic safety report production including PBRERs, PSURs, and DSURs
• Lead monthly signal detection and SIRC activities for established products
• Provide strategic and scientific input into regulatory submissions and safety documents
• Produce high-quality and timely responses to safety queries
• Retrieve and analyze relevant safety data from appropriate databases for signal evaluation
• Act as Safety Strategy and Management Team (SSaMT) leader for moderately complex products
• Perform end-to-end pharmacovigilance activities independently
• Mentor and guide junior team members within Patient Safety
• Ensure compliance with global and local Patient Safety policies, procedures, and regulatory requirements
• Support responses to regulatory authority queries and assess cross-country implications
• Raise safety concerns and escalate issues to senior staff when required
• Maintain effective communication with internal and external stakeholders
• Contribute to a performance-driven and collaborative safety culture

Qualification
• Degree in Biosciences or equivalent healthcare/pharmaceutical background

Experience
• 6 to 9 years of Patient Safety experience
• Total professional experience of 10 to 12 years
• Proven competency in patient safety and/or clinical development

Skills
• Comprehensive understanding of EU Patient Safety regulatory requirements
• Awareness of medico-legal aspects of patient safety
• Strong knowledge of pharmacovigilance processes and regulatory documentation
• Ability to work autonomously and within cross-functional global teams
• Strong analytical and scientific evaluation skills
• Effective communication skills across cultures
• High ethical standards and commitment to organizational values
• Ability to assimilate knowledge across disease and therapeutic areas

About the Company
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. With strong expertise in oncology, cardiovascular, renal, respiratory, and immunology, AstraZeneca combines deep scientific knowledge with collaboration and innovation to deliver life-changing medicines worldwide.