Provides Case Management expertise, leadership, and mentorship of relevant Therapeutic Areas case management members and Service Providers.
Deputizes for and assists the Case Medical Safety Lead, being the key contact to internal and external stakeholders for specific Case management activities.
Streamlines, supervises, and ensures consistent case medical oversight activities across GBUs.
Develops and oversees the implementation of robust corrective and preventative actions (CAPAs) by Case Medical Safety Expert (CMSE).
Represents the unit in transversal Case Medical oversight forums.
Ensures strong collaboration and CMSE group representation with cross-functional groups within and outside the company.
Requirements
MD or PharmD preferred; other healthcare professionals with adequate patient care experience can be considered (nurses, dentists, etc.)
8+ years of pharmacovigilance experience, or equivalent relevant pharmaceutical industry experience (clinical development, data management, etc.)
Minimum of 3 years of project management/coordination experience, highly desirable.
Thorough knowledge of Pharmacovigilance and Medical, Clinical processes and Regulations.
Expertise of Pharmacovigilance databases and MedDRA coding.
Fluent in English, able to communicate complex issues, medical and business concepts in English, both verbally and in writing.