Summary

-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams.

About the Role

Global Program Safety Lead - Immunology

Two positions available

• Safety Input and Team Participation: Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT). Responsible for managing safety issues from the formation of the GPT through Life Cycle Management.
• Signal Detection and Safety Management: Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant line functions, post-marketing data, and other sources.
• Documentation and Record Keeping: Ensure proper documentation, tracking, and record-keeping of medical safety activities for assigned compounds.
• Regulatory and Professional Inquiries: Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues.
• Safety Strategy Preparation: Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members.
• Departmental and Functional Goals: Contribute to and often lead the development of departmental and functional/business unit goals and objectives.
• Marketing Samples Distribution: Manage the distribution of marketing samples, where applicable.

• Medical Degree required
• 8+ years of experience in Big Pharma

• Clinical Research.
• Clinical Trials.
• Functional Teams.
• Leadership.
• Medical Strategy.
• Process Safety Management.
• Regulatory Compliance.
• Risk Management.
• Safety Science.

• Fluent English (both spoken and written) is mandatory.
• Additional languages are an advantage.