Global Product Safety Science Lead

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

📋 Description

• Lead and execute signal detection, evaluation, validation, and escalation tasks for designated products.

• Establish the strategy for safety signal detection methodologies and oversee signal tracking and management.

• Conduct and document benefit-risk assessments while ensuring the implementation of suitable risk management strategies.

• Oversee and perform evaluations for essential safety deliverables, including PSURs, DSURs, RMPs, and regulatory responses.

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

• Facilitate clinical safety science interactions with partner organizations and ensure the proper sharing of safety information as per the SDEA and effective collaboration within the JSMT.

• Provide scientific safety insights to the ISS Evaluation Committee as necessary.

• Collaborate cross-functionally on product quality escalations and, when needed, lead the preparation of medical impact Health Hazard Assessment statements.

• Serve as the Safety Science representative in the Medical Development Team, incorporating safety considerations into product development and lifecycle decisions.

• Offer clinical safety input into study design, execution, analysis, and interpretation, including responsibilities as Study-Level Safety Lead where applicable.

• Provide medical and pharmacovigilance expertise for clinical safety strategies, Target Product Profiles, and the maintenance of the RSI, including IB and CDS governance.

• Chair product-level Benefit Risk Teams and represent the BRT at the Benefit Risk Council.

• Act as the primary decision-maker for product-level safety matters, including signal validation and escalation.

• Manage interactions with external partners and service providers concerning product safety deliverables.

• Assist with product-level regulatory interactions, inspections, and audits.

• Mentor colleagues and foster capability development within the product safety team.

• Utilize and enhance safety systems, data visualization tools, and AI-driven analyses to support signal detection, safety evaluations, and decision-making.

• Identify opportunities for improvements in processes, data, and systems within Safety Science.

• Operate independently with accountability for assigned products, escalating complex or cross-product issues when necessary.

⛳️ Requirements

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

• Extensive experience in pharmacovigilance and safety science within a pharmaceutical or regulatory setting.

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

• Ability to analyze and synthesize medical and scientific safety data and contribute to scientific interpretations.

• Excellent communication and stakeholder collaboration skills.

• Proficient in Excel, database querying (e.g., SQL), and basic data visualization tools (e.g., Power BI, Spotfire), as well as 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 expertise in safety signal processes, aggregate report writing, safety risk communication, and safety risk management.

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

• Desired: Experience presenting medical safety information at Health Authority meetings.

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

• High proficiency in written and spoken English.

• Strong analytical capabilities.

• Effective communicator (oral, written, presentations) at all organizational levels.

• Ability to work efficiently towards achieving ambitious objectives.

• Sound judgment skills; capable of assessing and managing risks; confident, proactive, and decisive.

• Demonstrated ability to lead safety initiatives and scientific discussions.

• Strong team leadership skills.

• Proven relationship-building skills both internally and externally; a strong collaborator within the pharmacovigilance function, leadership, and the broader organization.

🏝️ Benefits

• Employees have the option to work remotely.