Description

In this role, you will strategically lead safety science activities for Sobi products, ensuring effective risk management and communication throughout the product lifecycle. You will collaborate with cross-functional teams and mentor junior scientists.

Requirements

• •Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
• •Minimum 8 years of relevant clinical practice, research experience, and/or employment in Drug Regulatory Agency or Pharmaceutical Industry R&D
• •At least 5 years involvement in signal evaluation and benefit/risk assessment of medicines in a global pharmaceutical company or Drug Regulatory Agency
• •Experience leading cross-functional global product safety management teams
• •In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)
• •High quality written and spoken English
• •Strong team-leadership capabilities and collaborative skills
• •Sound judgement and ability to assess and handle risks
• •Experience working with partner companies in global markets
• •Experience presenting medical safety information at Health Authority meetings
• •Expertise in various country/regional pharmacovigilance requirements

Tasks

• •Lead the multidisciplinary Benefit Risk Team for signal detection and risk management
• •Represent Safety Science as a subject matter expert in the Medical Development Team
• •Provide clinical safety input for clinical development activities
• •Manage interactions with partner companies regarding clinical safety
• •Develop and implement signal management activities
• •Offer medical and pharmacovigilance expertise for clinical safety strategy
• •Contribute to analysis planning and preparation of product safety documents
• •Lead Safety Science input for post-marketing activities and risk minimization measures
• •Provide safety expertise for regulatory submissions and geo-expansion
• •Support audits and inspections, representing Global Pharmacovigilance
• •Collaborate with cross-functional teams on safety strategies and risk management
• •Stay updated on global regulatory requirements and industry best practices
• •Mentor junior safety scientists within the team
• •Participate in scientific conferences and publications on product safety
• •Develop relationships with key opinion leaders and external experts