Global Product Safety Strategy Lead

Sobi - Swedish Orphan Biovitrum AB (publ); Basel; Hybrid; CHF 180,000 - 230,000; Full time

Job summary

Sobi, with its Basel premises, is seeking a Global Product Safety Science Lead to own product-level safety across the lifecycle. You will lead signal detection, risk management, and regulatory safety deliverables in collaboration with Safety Science and MDT teams.

The role combines scientific leadership with hands-on execution, shaping safety strategy, mentoring colleagues, and representing safety in cross-functional governance.

Qualifications

• MD/PharmD/PhD or Master’s in Life Sciences/Public Health.
• Strong pharmacovigilance and safety science experience in pharma or regulatory settings.
• Knowledge of global PV regulations (GVP, ICH E2E) and PV processes.
• Ability to analyze and interpret safety data and communicate findings.
• Excellent written and oral communication and stakeholder collaboration.
• Experience with development programs and marketed products in global safety.

Responsibilities

• Lead product-level safety activities, including signal detection, evaluation, and escalation.
• Set safety strategy, risk management, and oversight of key deliverables (PSURs, DSURs, RMPs).
• Translate safety insights into actionable recommendations for regulatory interactions.
• Lead clinical safety interactions with partner companies and oversee JSMT setup.
• Chair Safety governance forums (BRTs/BRC) and represent safety in MDTs.
• Mentor teammates and support capability development within Safety Science.
• Collaborate cross-functionally to integrate safety into development and lifecycle decisions.

Skills

Pharmacovigilance

Safety science

Signal detection

Cross-functional leadership

Stakeholder collaboration

Excel

SQL

Power BI

Spotfire

Safety data interpretation

Education

MD

PharmD

PhD

Master’s in Life Sciences/Public Health

Tools

Veeva Vault

Analytics dashboards

Job description

Sobi, with its Basel premises, is seeking a Global Product Safety Science Lead to own product-level safety across the lifecycle. You will lead signal detection, risk management, and regulatory safety deliverables in collaboration with Safety Science and MDT teams.

The role combines scientific leadership with hands-on execution, shaping safety strategy, mentoring colleagues, and representing safety in cross-functional governance.