Senior Director – PV Case Management, ICSR
Eli Lilly and Company
Senior Director, Global Patient Safety Science
Chiesi Group
full-time
Posted on:
Origin: • 🇮🇹 Italy
Visit company websiteJob Level
Senior
About the role
- Lead the Patient Safety Science team of product assigned patient safety physicians, supporting them for safety surveillance and risk management activities of their assigned Chiesi products
- Ensure up-to-date oversight of the emerging safety profile for all Chiesi products and the corresponding safety and risk management strategies
- Provide strategic medical and scientific leadership for patient safety across Chiesi’s product portfolio
- Oversee patient safety assessments during due diligence, clinical development, and post-marketing phases
- Ensure the delivery of Patient Safety Science activities including support of clinical trials, delivery of aggregate reports, signal detection, signal assessment and safety signal management, safety risk mitigation activities and the appropriate communication of safety messaging across internal and external stakeholders
- Guide the preparation and maintenance of regulatory safety documents (e.g., RMPs, PSURs, DSURs)
- Represent Patient Safety in internal and external meetings, including interactions with Health Authorities
- Collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory Affairs, and external partners
- In collaboration with the QPPV, ensure compliance with health authority requirements and take the lead in assigned areas for inspections and audits and implement appropriate remediation where required
- Active member of the GRAPS Leadership Team and contribute to the Regulatory Affairs and Patient Safety vision
Requirements
- At least 10 years of experience in global medical safety / pharmacovigilance roles in a global pharmaceutical/biotech company, working with development programs, regulatory submissions and post-marketing safety surveillance
- Proven team leadership and line management experience and skills within a patient safety or similar setting
- Advanced knowledge of PV regulations, Health Authority expectations and cross-functional/organizational working, particularly in due diligence, partnerships and clinical development
- Diverse experience across pharmacovigilance, including systems, operations and safety science at global and local levels, for different types of products (small molecules, biologics, combination products)
- Medical degree (MD)
- Excellent command of English (spoken and written)
- Relationship building and collaboration skills
- Strong ethical sense combined with quality and patient safety mindset
- Strategic vision and ability to work with a team to successfully deliver
