Global Product Safety Science Leader

Sobi - Swedish Orphan Biovitrum AB (publ); Stockholms kommun; On-site; SEK 1,200,000 - 1,800,000; Full time

Job summary

Sobi - Swedish Orphan Biovitrum AB (publ) is seeking a Global Product Safety Science Lead (GPSSL) to own product-level safety across the lifecycle. The role combines scientific leadership with hands-on execution to ensure high-quality safety deliverables and proactive risk management.

As Safety Science lead, you will drive signal detection, risk assessments and strategic safety plans in collaboration with MDTs, BRTs and external partners while ensuring adherence to GVP and regulatory

Qualifications

• MD, PharmD, PhD or Master’s in Life Sciences/Public Health.
• Solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory environment.
• Strong knowledge of global PV regulations (GVP, ICH E2E) and PV processes.
• Ability to analyse, synthesize medical safety data and contribute to scientific interpretation.
• Strong communication and stakeholder collaboration skills.

Responsibilities

• Act as the Safety Science representative in MDT and integrate safety into product development and lifecycle decisions.
• Provide clinical safety input into study design, conduct, analysis and interpretation.
• Lead safety activities and scientific discussions, including signal process and risk communication.
• Chair product-level Benefit Risk Teams and represent the BRT at the BRC.
• Collaborate with external partners and support regulatory interactions, inspections, and audits.
• Mentor colleagues and develop capabilities within the safety team.

Skills

English proficiency

Analytical skills

Communication skills

Decision making

Leadership

Team collaboration

Safety signal process

Education

MD/PharmD/PhD or Life Sciences Master

Tools

Excel

SQL

Power BI

Spotfire

AI tools

Job description

Sobi - Swedish Orphan Biovitrum AB (publ) is seeking a Global Product Safety Science Lead (GPSSL) to own product-level safety across the lifecycle. The role combines scientific leadership with hands-on execution to ensure high-quality safety deliverables and proactive risk management.

As Safety Science lead, you will drive signal detection, risk assessments and strategic safety plans in collaboration with MDTs, BRTs and external partners while ensuring adherence to GVP and regulatory