Medical Director, Senior Safety Physician

Role Summary

Medical Director, Senior Patient Safety Physician – a senior leader within Patient Safety responsible for clinical understanding and judgement in benefit risk assessments for AstraZeneca products, coaching junior staff, and ensuring compliance with Good Clinical and Pharmacovigilance Practice and regulatory requirements. Stay aligned with medical developments to inform safety strategy.

Responsibilities

• Providing strategic Patient Safety input to drug development and post-marketing programs
• Collaboration with team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings
• Ensuring expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation)
• Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee
• Lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities
• Lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs
• Participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may represent Patient Safety in cross-functional discussions with internal and external partners

Qualifications

• Required: BS degree in medicine and experience as a physician or academic clinician
• Required: 7+ years of proven experience
• Required: Extensive experience in Pharmacovigilance, with clear evidence of delivering to a high standard
• Required: Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field
• Required: Experience in designing, supervising and implementing clinical trials and interpreting trial results
• Required: Strategic leadership of complex drug projects
• Required: Understanding of the medico-legal aspects of pharmacovigilance
• Required: Proven leader of cross-functional delivery teams
• Required: Demonstrated ability to influence key business partners within and outside of company
• Required: Proficiency with both written and verbal communications

Skills

• Strategic healthcare leadership
• Pharmacovigilance and safety surveillance
• Regulatory submission support
• Cross-functional collaboration
• Communication and influencing abilities

Education

• BS degree in medicine
• Preferred: PhD in scientific field

Additional Requirements

• 5+ years of proven experience (preferred)