Medical Director- Patient Safety Physician

Job description

Job Title: Medical Director, Patient Safety Physician GCL: F Introduction to role: Are you ready to build clinical safety plans that safeguard patients while accelerating breakthrough medicines across a diverse pipeline? How would you use your medical judgment to anticipate and mitigate risk before it reaches the clinic or the market? As Medical Director, Patient Safety Physician, you will coordinate the clinical safety agenda for assigned programs across all stages of development and post-approval. You will partner with scientific, clinical, regulatory and informatics experts to turn sophisticated safety evidence into clear, decisive actions that influence program direction, labelling and submissions. This role gives you the freedom to ask the right questions, make ambitious decisions, and focus efforts where they have the biggest impact on patients and the business. Accountabilities: • Lead the approach to clinical safety for assigned products during development and after launch. Align with governance. Identify risks and propose mitigation and minimisation measures. Set safety go/no-go criteria and give to TPP/TPC. Develop safety submission strategies, respond to regulatory safety questions, and lead the risk part of benefit–risk assessments. • Review and endorse core patient risk management plans and logs; provide medical expertise to safety specifications, pharmacovigilance plans and risk-minimisation activities; ensure appropriate implementation within product reference safety information globally. • Represent Patient Safety on clinical and project teams; establish and chair Safety Management Teams as needed; give to ad-hoc teams addressing urgent safety issues; present safety information at investigator and commercial meetings. • Provide strategic clinical safety input into development planning; define project-specific safety requirements; review and approve investigator brochures, protocols, informed consents and final study reports; support external data monitoring committees where appropriate. • Supervise surveillance activities including medical review of individual cases, signal detection and evaluation; direct use of data sources and database searches; collaborate with external providers; deliver clear, fit-for-purpose safety evaluations; prepare labelling updates and responses to local label deviations; develop Developmental Core Safety Information for assigned development products. • Provide medical input and review for periodic reports such as PBRERs, PSURs, PADERs and DSURs; lead patient safety contributions to global submissions (NDA, BLA, MAA) and renewals for new products, formulations and indications. • Understand and support the role of the QPPV; give to maintaining the pharmacovigilance system and processes; ensure inspection readiness and the integrity of safety agreements. • Advise on licensing agreements; participate in regulatory and non-regulatory meetings with authorities, partners and consultants; support due diligence activities and, as appropriate, product liability litigation. • Initiate and lead process improvement initiatives within Patient Safety; apply safety science, informatics, modeling and simulation; raise issues to senior management promptly and clearly. • Mentor and train junior colleagues in signal evaluation, risk management, and safety reporting. Collaborate across functions, cultures, and with outside partners to promote high-quality safety data evaluation. Essential Skills/Experience: • Medical degree or equivalent experience (eg MD, MBBS) • At least 2 years of clinical experience post-registration • High level of medical competence, with an ability to balance this with industry standards to achieve business goals • A minimum of 2 years' experience in Drug Development and Patient Safety is required. Most of this time should be in Patient Safety within the industry. Evidence of delivery must be demonstrated. • It is not required to meet the minimum experience length or complete the UK advanced clinical training in pharmaceutical medicine. cine. These details indicate the level of knowledge, expertise, and recognition encouraged for this job. Desirable Skills/Experience: • UK physicians will generally be encouraged to have completed advanced medical education in Pharmaceutical Medicine or possess equivalent experience • MSc/PhD or equivalent experience in scientific field • Able to work across TAs and Functions • Experience of supervising Patient Safety colleagues • A demonstrated ability to understand epidemiological data • Dedication to Customers and Integrity; Strategic Leadership; Acts Conclusively; Drives Accountability; Works Collaboratively; Develops People and Organisation • Drug Development Experience and Application of Disease and TA knowledge; Integrative thinking; Excellence in pharmacovigilance; Patient Benefit–risk assessment • Conceptual thinking; Influencing; Initiative; Innovation; Business relationship management When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca: Join a science-led global organization where evidence drives bold decisions and diverse guides collect to reinvent the future of medicine. You will work at the interface of early and late devel