CRM Consultant at iGoMoon driving business growth through HubSpot implementations and solutions. Collaborating with teams to enhance customer success and CRM effectiveness.
About the role
- Joining the innovative Cardio Renal Metabolism team as Global Program Safety Lead. Collaborating with expertise while managing safety strategies for clinical development.
Responsibilities
- Provide expert safety input to the clinical development program for assigned projects/products
- Actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT)
- Lead the Safety Management Team (SMT)
- Responsible for managing safety issues from the formation of the GPT through Life Cycle Management
- Own the projects/products safety strategy and lead the production of medical safety deliverables
- Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet, addressing safety issues in all project/product indications
- Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information
- Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members
- Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues
- Contribute to and often lead the development of departmental and functional/business unit goals and objectives
- Proactively engages in the development of competencies across the Medical Safety Function
Requirements
- Medical Degree or equivalent is preferred; PhD, PharmD or equivalent graduate level health care professional degree required
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development in a major pharmaceutical company (of which 2 years in a global position)
- Including 2 years in safety at an operational or medical position
- Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
- Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
- Experience with (safety or others) issue management
- Experience in leading cross-functional, multicultural teams
- Languages: Fluent English (both spoken and written) is mandatory.
- Additional desirable skills: Additional languages are an advantage. CRM experience
Benefits
- Work with cutting-edge technology
- Collaborate with experts
- Drive excellence in patient safety
- Opportunities for professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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