Medical Director, Senior Patient Safety Physician
$249.83k - $374.74kAstraZeneca
AstraZeneca seeks an experienced physician to lead clinical safety and benefit-risk management for assigned products across their lifecycle. The role involves medical strategy development, safety surveillance, regulatory submissions, and cross-functional collaboration within a global environment based in Boston.
Responsibilities
- Lead clinical safety strategy and drive medical evaluation of safety data for assigned products
- Provide medical oversight of signal detection, safety surveillance, and risk evaluation activities
- Lead and review regulatory safety deliverables including DSURs, PBRERs, and global submissions
- Serve as patient safety representative in clinical project teams and build cross-functional partnerships
- Mentor colleagues and support due diligence and business development activities as needed
Requirements
- Medical degree (MD, MBBS, or equivalent)
- Clinical practice experience following medical qualification
- Significant pharmaceutical or biotech industry experience in clinical safety and pharmacovigilance
- Strong knowledge of benefit-risk assessment, risk management, and global pharmacovigilance regulations
- Experience preparing or reviewing global regulatory safety documents and submissions
- Proven ability to influence and lead within matrix organizational structures
Compensation: $249,827 - $374,740 base
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