Clinical Safety Physician (m/f/d)

Skilled Recruitment Solutions GmbH; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Skilled Recruitment Solutions GmbH is seeking a Senior Medical Safety Lead to oversee strategic safety governance across assigned clinical assets and ensure proactive risk management.

The role directs safety surveillance, leads cross-functional safety boards with clinical, regulatory, and operations teams, and provides medical review for regulatory dossiers while interacting with health authorities globally. Fluent English required.

Qualifikationen

• MD or equivalent licensed physician.
• Extensive pharmacovigilance/clinical safety experience.
• Strong knowledge of global regulatory frameworks and reporting.
• Ability to synthesize medical data into risk assessments and communicate to executives.

Aufgaben

• Strategic Safety Governance: Act as primary medical authority for clinical assets, driving risk assessment and benefit-risk balance throughout development lifecycle.
• Surveillance & Signal Assessment: Oversee safety surveillance, signal management, and medical evaluation of emerging data to mitigate risk.
• Interdisciplinary Leadership: Lead cross-functional safety boards, guiding clinical, regulatory, and operational teams on safety strategy and decisions.
• Regulatory Dossier Ownership: Provide medical review and input for safety documentation and regulatory updates.
• Individual Case Review: Evaluate serious adverse events to ensure accuracy and compliance with international standards.
• Agency Interactions: Represent medical safety in discussions with regulators and advisory boards.

Kenntnisse

MD/Physician

Pharmacovigilance

Regulatory knowledge

Analytical skills

Fluent English

Ausbildung

MD or equivalent

Jobbeschreibung

• Strategic Safety Governance: Serve as the primary medical authority for assigned clinical assets, driving end-to-end risk assessment and benefit-risk balance throughout the development lifecycle.
• Surveillance & Signal Assessment: Direct continuous safety surveillance, signal management, and medical evaluation of emerging clinical data to ensure proactive risk mitigation.
• Interdisciplinary Leadership: Lead cross-functional safety boards, guiding clinical, regulatory, and operational teams on drug safety strategy and decision-making.
• Regulatory Dossier Ownership: Provide medical review and strategic input for critical safety documentation, periodic regulatory updates, and risk mitigation plans submitted to global health authorities.
• Individual Case Review: Perform expert medical evaluations of serious adverse event reports to guarantee clinical accuracy and compliance with international standards.
• Agency Interactions: Function as the key medical safety representative during scientific discussions with regulatory bodies and external safety advisory boards.

Your Profile

• Medical Credentials: Fully licensed Physician (MD or equivalent clinical degree).
• PV Expertise: Extensive background in industry pharmacovigilance, clinical safety, or drug development (senior-level medical safety experience).
• Regulatory Acumen: Solid mastery of global regulatory frameworks, clinical trial safety standards, and global reporting expectations.
• Analytical & Communication Skills: Strong ability to synthesize complex medical data into clear risk assessments and articulate strategies to executive stakeholders in fluent English.