Global Product Safety Science Lead — Strategy & Impact

Sobi; United States; À distance; USD 140 000 - 210 000; Plein temps

Résumé du poste

Sobi seeks a Product Safety leader to oversee safety signal detection, governance and risk management for assigned products. You will drive safety data analysis, regulatory deliverables, and cross-functional collaboration across Medical, Regulatory and External partners.

The role requires strong pharmacovigilance expertise, global regulatory knowledge, and ability to lead cross-functional teams in a fast-paced, international setting; English proficiency and excellent communication are essential.

Qualifications

• MD, PharmD, PhD or Master’s in Life Sciences/Public Health.
• Solid experience in pharmacovigilance and safety science.
• Strong knowledge of global PV regulations (GVP, ICH E2E).
• Proficiency in analyse, synthesize medical & scientific safety data and contribute to interpretation.
• Strong communication & stakeholder collaboration skills.
• Proficiency in Excel, database querying (e.g., SQL), and basic data visualization (Power BI, Spotfire), AI-related tools.

Responsabilités

• Lead safety signal detection and oversight for assigned products.
• Prepare and review safety deliverables (PSURs, DSURs, RMPs).
• Integrate safety into MDT and product lifecycle decisions.
• Lead product safety governance and decision-making (BRTs, BRC).
• Collaborate with external partners on safety deliverables.
• Support regulatory interactions and audits at product level.

Connaissances

English proficiency

Analytical skills

Communication skills

Leadership

Risk assessment

Cross-functional collaboration

Formation

MD

PharmD

PhD

Master’s in Life Sciences/Public Health

Outils

Excel

SQL

Power BI

Spotfire

AI tools

Description du poste

Sobi seeks a Product Safety leader to oversee safety signal detection, governance and risk management for assigned products. You will drive safety data analysis, regulatory deliverables, and cross-functional collaboration across Medical, Regulatory and External partners.

The role requires strong pharmacovigilance expertise, global regulatory knowledge, and ability to lead cross-functional teams in a fast-paced, international setting; English proficiency and excellent communication are essential.