Global Product Safety Science Lead

About the role

The Global Product Safety Science Lead (GPSSL) is the primary safety owner for assigned products, driving safety strategy, signal detection and benefit‑risk assessments across the product lifecycle.

Key responsibilities

• Lead signal detection, evaluation, validation and escalation for assigned products and set the methodology for safety signal tracking.
• Conduct benefit‑risk evaluations, develop risk‑management strategies and oversee preparation of key safety deliverables such as PSURs, DSURs, RMPs and regulatory responses.
• Represent Safety Science in the Medical Development Team, providing clinical safety input into study design, conduct and interpretation.
• Chair product‑level Benefit Risk Teams, act as primary decision‑maker for safety issues and represent the team at the Benefit Risk Council.
• Collaborate with external partners, service providers and regulatory authorities on safety deliverables and inspections.

Required profile

• MD, PharmD, PhD or Master’s in Life Sciences/Public Health.
• Extensive experience in pharmacovigilance and safety science within pharmaceutical or regulatory settings.
• Strong knowledge of global PV regulations (GVP, ICH E2E) and experience with products that have market approvals.
• Proven ability to lead cross‑functional global product safety teams and communicate scientific safety data.

Required skills

• Advanced Excel.
• Database querying (SQL).
• Data visualization tools (Power BI, Spotfire).
• AI‑enabled analysis platforms (e.g., Veeva Vault).