Beschreibung

As the Global Product Safety Science Lead, you will strategically oversee safety science activities throughout the product lifecycle, ensuring effective communication and collaboration with internal and external stakeholders while managing clinical safety and risk.

Anforderungen

• •Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
• •8+ years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency or R&D in the Pharmaceutical Industry
• •5+ years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a 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)
• •Experience working with partner companies in global markets
• •Experience presenting medical safety information at Health Authority meetings
• •Fluency in written and spoken English
• •Strong communication and team-leadership capabilities
• •Sound judgment skills and ability to assess and handle risks
• •Expertise in resolving or escalating issues as appropriate

Aufgaben

• •Lead the multidisciplinary Benefit Risk Team for product safety
• •Drive signal detection, analysis, risk management, and safety labeling
• •Provide pharmacovigilance and clinical safety expertise at the product level Medical Development Team
• •Contribute to clinical development through design, conduct, data analysis, and interpretation
• •Oversee safety science interactions with partner companies
• •Develop and implement signal management activities
• •Provide medical and pharmacovigilance expertise for clinical safety strategy and regulatory documents
• •Lead Safety Science input for post-marketing activities and risk minimization measures
• •Support regulatory submissions and product expansion activities
• •Respond to medical safety-related inquiries and assist with audits and inspections
• •Represent Global Pharmacovigilance in interactions with stakeholders, including Regulatory Authorities and Key Opinion Leaders