Medical Director/ Senior Patient Safety Physician
On-siteGöteborg, Västra Götaland, Sweden
Job Summary
Lead clinical safety strategy and governance for assigned AstraZeneca drug projects across all development stages and post-marketing settings. Provide senior medical expertise on product safety profiles, driving adverse event reviews, risk management initiatives, and signal detection to inform benefit-risk assessments and go/no-go criteria. Deliver medical input into core safety documents including PBRERs, PSURs, and regulatory submissions such as NDAs and BLAs, while ensuring consistent safety messaging and inspection readiness. Collaborate with cross-functional teams in Clinical Development, Regulatory Affairs, and safety science to support clinical development planning and project-specific safety requirements.
Required Qualifications
- Medical degree such as MD or MBBS
- At least 2 years of post-registration clinical experience
- At least 5 years of experience in Drug Development and/or Patient Safety
- Patient Safety
- Strong understanding of the pharmaceutical/biopharmaceutical industry, particularly clinical research and global regulatory requirements
- Experience in expedited and periodic safety reporting, signal detection, safety evaluation, and risk management
- Strong clinical credibility and scientific judgement, with the ability to interpret complex safety data and apply benefit-risk thinking
- Ability to translate safety insights into clear, practical actions across development and post-marketing activities
- Strong communication and influencing skills, with the ability to work effectively across cross-functional and cross-cultural teams
- Ability to balance scientific rigor with business priorities while maintaining a clear focus on patient safety
- Fluency in written and spoken English
Desired Qualifications
- An MSc, PhD, or other advanced scientific qualification
- Experience across multiple therapeutic areas or functions
- Experience supervising, mentoring, or developing colleagues in Patient Safety
- Ability to interpret and apply epidemiological data
- Additional training in Pharmaceutical Medicine or a related discipline
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