Global Product Safety Science Lead: Strategy & Signals

Sobi - Swedish Orphan Biovitrum AB (publ); Cambridge; Vor Ort; GBP 90.000 - 130.000; Vollzeit

Zusammenfassung

Sobi is seeking a Global Product Safety Science Lead to guide safety surveillance for assigned products across the lifecycle. You will chair benefit–risk discussions and drive risk management, ensuring safety is embedded in development and regulatory interactions with GVP/GCP alignment.

The role partners with the Global PV team and MDT to deliver high‑quality safety deliverables and strategic safety input across projects in a fast‑moving biopharma environment.

Qualifikationen

• Required: MD, PharmD, PhD or Master’s in Life Sciences/Public Health.
• Solid experience in pharmacovigilance and safety science within pharma/regulatory.
• Strong knowledge of global PV regulations (GVP, ICH E2E).
• Ability to analyse and interpret medical safety data with stakeholders.

Aufgaben

• Lead safety activities and lifecycle safety for assigned products, including signal detection and evaluation.
• Set strategy for safety signal detection and oversight of safety signals.
• Drive benefit‑risk assessments and implement risk‑management strategies.
• Lead preparation and approval of PSURs, DSURs, RMPs and regulatory responses.
• Collaborate with MDT and cross‑functional teams to embed safety in development decisions.
• Mentor colleagues and contribute to capability development in Safety Science.

Kenntnisse

Pharmacovigilance

Safety science

Signal detection

PV regulations

Study design input

Data visualization

SQL

Excel

Leadership

Stakeholder mgmt

Ausbildung

MD/PhD/PharmD or MSc in Life Sciences

Tools

SQL

Power BI

Spotfire

Veeva Vault

Jobbeschreibung

Sobi is seeking a Global Product Safety Science Lead to guide safety surveillance for assigned products across the lifecycle. You will chair benefit–risk discussions and drive risk management, ensuring safety is embedded in development and regulatory interactions with GVP/GCP alignment.

The role partners with the Global PV team and MDT to deliver high‑quality safety deliverables and strategic safety input across projects in a fast‑moving biopharma environment.