Job Title: Associate Director, Patient Safety Scientist
Location: [Insert Location Here]
Global Career Level: E
Introduction to Role: The Associate Director, Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and related documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports. The Associate Director also leads meetings and presents safety data and analyses.
Accountabilities:
Pharmacovigilance and Risk Management:
Lead and conduct proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans in partnership with the GSP and others.
Represent Patient Safety on cross-functional project teams for marketed products and/or developmental compounds.
Present safety information at external meetings.
Leadership & Data Review:
Perform duties as a Safety Strategy and Management Team (SSaMT) leader.
Present issues to the Safety Information Review Committee (SIRC), leading the data evaluation and discussion with the SIRC Chair, GSP, and key stakeholders.
Produce accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Collaboration and Strategic Input:
Collaborate with GSP and Clinical representatives to author the Reference Safety Information (RSI) for assigned marketed products and/or development products.
Proactively evaluate clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other sources to establish the safety profile of drugs and manage the risk to patients.
Author or provide strategic input to regulatory documents such as PBRERs, PSURs, DSURs, ensuring compliance with timelines and processes.
Team Development & Mentorship:
Contribute to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity.
Train junior team members in Patient Safety tools and systems.
Author or provide strategic input to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA).
Essential Skills/Experience:
Degree in biosciences or an equivalent healthcare or pharmaceutical industry background with proven competency in patient safety/clinical development.
Comprehensive understanding of applicable Patient Safety regulatory obligations and policies.
9 to 11 years of Patient Safety experience, with a total of 12 to 14 years of relevant experience.
Communication Skills:
Well-developed interpersonal skills and cultural sensitivity.
Ability to network with other functions globally.
Impact on Business Results:
Quality and timeliness of work through surveillance and case handling activity.
Ensure timely information is provided for regulatory reporting requirements, safety due diligence, and correct labeling through safety surveillance activities.
Internal and External Contacts/Customers:
Patient Safety personnel at all levels.
Regulatory Affairs and other AstraZeneca personnel.
Leadership Skills:
Passion for Customers: Engages directly with customers to ensure delivery of complete solutions.
Thinks Strategically: Applies a broad perspective to challenge and adapt current approaches.
Acts Decisively: Makes effective decisions under pressure, seeking support when needed.
Drives Performance: Holds team accountable for quality standards by clarifying objectives and timelines.
Works Collaboratively: Integrates diverse views and collaborates across functions.
Develops People and Organisation: Provides support and feedback to junior staff and focuses on self-development.
Work Model:
Minimum of three days per week in-office, with flexibility to accommodate individual needs.
About AstraZeneca: At AstraZeneca, we follow the science and pioneer new frontiers. Our ambition is to eliminate cancer as a cause of death. Join our team dedicated to Oncology, where we fuse cutting-edge science with the latest technology to achieve breakthroughs. We are committed to collaborative research and offer a rewarding career contributing to life-changing medicines.
Ready to make a difference? Apply now!
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