P2620 - Safety Physician Oncology

In this role you actively oversee safety in oncology and antibiotics during early development, collaborating with internal experts and external partners. You will contribute medical input for accelerated approval documents, investigator brochures, and development safety reports, while leading safety surveillance and signal detection activities. You will oversee outsourced pharmacovigilance activities and help implement a dedicated signal detection tool within a cross-functional team. The role involves collaboration in study teams, IDMC meetings, and safety task forces to drive patient safety and development success.

• international, dynamic environment
• cross-functional collaboration
• exposure to diverse clinical development areas
• focus on innovation and entrepreneurship
• Equal-Pay certified
• long-term vision

• Evaluate safety profile of products in collaboration with company experts and partners
• Provide medical input for safety-related documents (accelerated approval submissions, investigator brochures, Development Safety Update Reports)
• Lead safety surveillance including medical review of safety cases and signal detection in the safety database
• Oversee outsourced PV vendor activities to ensure quality and compliance
• Develop and lead a signal detection tool with clinical medicine, biometry, and clinical pharmacology teams
• Participate in study teams, IDMC meetings, and internal safety task forces

• MD with experience in clinical safety in early drug development in a global pharma or CRO
• At least 5 years of direct clinical safety experience in biotech/pharma
• First experience in oncology drug development is an asset
• Strong leadership, collaboration, communication, and decision-making skills
• Ability to prioritize, meet deadlines with attention to quality
• Proficiency with Microsoft 365; familiarity with digital tools is a plus
• Excellent written and verbal communication in English; French an asset

• leadership
• collaboration
• communication
• safety database medical review
• signal detection in pharmacovigilance
• oversight of PV vendor activities