Global Safety Lead Oncology (all genders)

Your role
The Global Safety Lead Oncology will closely work with the Global Program Safety Lead (GPSL) to provide integrated medical safety strategies for assigned development programs or marketed products and will oversee the effective delivery of pharmacovigilance outputs including proactive safety surveillance, signal activities and benefit-risk management.

Key Responsibilities:

• Set medical safety strategic direction and provide strong and visible safety scientific leadership
• Ensure oversight of emerging safety profiles, including medical review of individual case safety reports, signal detection & evaluation, periodic safety reports, risk benefit evaluation and risk management
• Contributions to Pharmacovigilance Advisory Board and other R&D governance bodies
• represent GPS on cross-functional teams
• represent GPS at submission teams and provide safety strategic input into submission documents
• chair cross-functional safety teams
• represent GPS on safety aspects for the product on monitoring committees (e.g. SMC/IDMC members)
• preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, effective collaboration with colleagues from partnership companies for co-development or co-marketing
• act as a subject-matter expert on medical safety in interactions/discussion/negotiations with regulatory authorities
• ensure effective communication of product-related aspects in audits and regulatory authority inspections;
• provide medical safety expertise for due diligence activities if required

Who you are
Education: Physician with clinical experience preferred.
Experience:

• several years of medical experience in Oncology/Haematology is preferred.
• Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations
• Excellent knowledge of product development process and experience of cross-functional teamwork
• Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or reviews
• Experienced in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological)
• Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics

Skills: Strong decision-making, negotiation, and influencing skills; excellent verbal and written communication in English.

Department:HC-RD-RSBD Medical Safety Oncology

Job Evaluation:AT - Expert 4