Global Product Safety Science Lead

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Conduct and oversee signal detection, assessment, validation, and escalation activities for designated product(s).

• Establish the strategy for safety signal detection methodologies, monitoring, and oversight of safety signals for assigned products.

• Lead, execute, and document benefit-risk evaluations while ensuring that suitable risk management strategies are put in place.

• Manage and conduct evaluations for the creation, review, and approval of essential safety deliverables (e.g., PSURs, DSURs, RMPs, regulatory submissions).

• Convert safety data insights into practical recommendations for product-level benefit-risk discussions and regulatory engagements.

• Serve as the Safety Science representative within the Medical Development Team (MDT) and guarantee the integration of safety considerations into product development and lifecycle decisions.

• Offer clinical safety insights for study design, execution, analysis, and interpretation, including responsibilities as the study-level Safety Lead when applicable.

• Chair product-level Benefit Risk Teams (BRTs) to ensure their effective operation in accordance with standard operating procedures (SOPs).

⛳️ Requirements

• MD, PharmD, PhD, or Master’s degree in Life Sciences/Public Health.

• Comprehensive experience in pharmacovigilance and safety science within a pharmaceutical or regulatory context.

• In-depth knowledge of global pharmacovigilance regulations (e.g., GVP, ICH E2E), as well as pharmacovigilance processes and practices.

• Capability to analyze and synthesize medical and scientific safety data, contributing to scientific interpretations.

• Excellent communication and stakeholder collaboration abilities.

• Proficiency in Excel, database querying (e.g., SQL), and basic data visualization tools (e.g., Power BI, Spotfire), including AI-related technologies.

• Experience with development programs and products that have received market approvals.

• Proven track record of leading cross-functional global product safety management teams, successfully implementing medical safety strategies, with experience in safety signal processes, aggregate report writing, safety risk communication, and safety risk management.

• Preferred: Experience collaborating with partner companies to successfully develop and market products in global markets.

• Experience delivering medical safety information at Health Authority meetings.

• Demonstrated expertise in understanding, interpreting, and applying various country and regional pharmacovigilance requirements.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and growth.

• Collaborative work environment with a focus on innovation.