Global Patient Safety Physician

BioTalent; Göteborgs kommun; On-site; SEK 1,000,000 - 1,800,000; Full time

Job summary

BioTalent is seeking a Global Patient Safety Physician in Sweden to lead safety strategy across development and marketed products.

You will provide medical leadership for benefit-risk assessment, signal management, safety surveillance, risk management and global regulatory submissions, working cross-functionally to shape patient safety strategy throughout the product lifecycle.

Qualifications

• MD or MBBS qualification.
• 5+ years' experience in Drug Development and/or Pharmacovigilance.
• Expertise in benefit-risk assessment, signal detection, safety evaluation, and risk management.
• Experience contributing to regulatory safety documents (DSURs, PSURs/PBRERs, submissions).
• Strong understanding of global regulatory requirements and clinical development.
• Excellent stakeholder management and influencing skills.

Responsibilities

• Lead clinical safety strategy across development and marketed products.
• Provide medical leadership for benefit-risk assessment, signal management, safety surveillance, and risk management.
• Drive global regulatory submissions and safety documentation.
• Collaborate cross-functionally to shape patient safety strategy through the product lifecycle.

Skills

MD/MBBS

Pharmacovigilance

Drug development

Signal detection

Safety evaluation

Regulatory submissions

Stakeholder management

Education

MD/MBBS degree

Job description

Global Patient Safety Physician, Permanent, Sweden

BioTalent is collaborating with a leading global biopharmaceutical and searching for an experienced Patient Safety Physician to lead clinical safety strategy across innovative development and marketed products.

You will provide medical leadership for benefit-risk assessment, signal management, safety surveillance, risk management and global regulatory submissions. You will work cross-functionally and help shape patient safety strategy throughout the product lifecycle.

Key requirements:

• MD or MBBS qualification
• 5+ years' experience in Drug Development and/or Pharmacovigilance
• Strong expertise in benefit-risk assessment, signal detection, safety evaluation, and risk management
• Experience contributing to regulatory safety documents (DSURs, PSURs/PBRERs, submissions)
• Strong understanding of global regulatory requirements and clinical development
• Excellent stakeholder management and influencing skills