Medical Director, Senior Safety Physician
AstraZeneca
Pharmaceutical Industry
Barcelona, Cataluña - Spanien
Director
Experteer Overview
In this role you drive safety strategy for AstraZeneca's 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.
Responsibilities
- 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
Key requirements
- 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 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
Description
In this role you drive safety strategy for AstraZeneca's products, guiding benefit–risk assessments and regulatory submissions. You lead and…
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