20 sep
|
AstraZeneca
|
Barcelona
20 sep
AstraZeneca
Barcelona
Overview
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In this role you drive safety strategy for AstraZenecas products, guiding benefit–risk assessments and regulatory submissions. You lead and mentor the Patient Safety team, shaping the safety culture and ensuring adherence to GCP and pharmacovigilance standards. You collaborate across functions to translate clinical data into safety strategies, leveraging expert input for trial design, surveillance, and regulatory communications. You will influence governance discussions and represent patient safety in cross-functional forums, delivering high-quality safety evaluations that support product development and post-marketing activities.
Responsabilidades
Provide strategic patient safety input to drug development and post-marketing programs
Collaborate with team members on safety surveillance and high-quality safety evaluations
Contribute expert input to design, interpretation, and use of modelling and simulation tools
Lead safety discussions with governance boards and Patient Safety Peer Review Committee
Direct safety strategy for regulatory communications and oversight of submission documents
Lead medico-scientific contributions to RMPs, PBRERs, DSURs
Participate in advisory discussions to support other Patient Safety teams and represent safety in cross-functional discussions
Requisitos principales
BS degree in medicine and experience as a physician or academic clinician
7+ years of proven experience
Extensive experience in Pharmacovigilance with high-quality delivery
Detailed xqbhyrx understanding of pharmaceutical safety, reporting and surveillance
Experience in designing, supervising and interpreting clinical trials
Strategic leadership of complex drug projects
Understanding of medico-legal aspects of pharmacovigilance
Proven ability to influence key business partners and cross-functional teams
Proficiency in written and verbal communications
leadership
influence and negotiation
cross-functional collaboration
Pharmacovigilance
Safety surveillance
RMPs
📌 Medical Director, Senior Safety Physician (Barcelona)
🏢 AstraZeneca
📍 Barcelona