What are the responsibilities and job description for the Medical Director Cambridge, MA position at Jobleads-US?
Job Description
Nearly 37 million Americans are affected by Chronic Kidney Disease.
At Jobleads-us, we take this number seriously and strive to better the lives of those impacted by kidney disease.
Our team challenges the status quo to develop unique therapeutics that set new standards of care for people living with kidney disease.
Medical Director Role
- Analyzes, reviews, and interprets clinical and post-marketing safety data.
- Liaises with cross-functional teams to manage safety and risk management activities.
- Conducts signaling and safety surveillance processes, including identification, assessment, and communication of confirmed safety signals.
- Provides medical safety expertise to author and review critical documents.
- Collaborates with Regulatory Affairs to report pharmacovigilance and drug safety information to regulatory agencies.
Essential Functions
Safety Strategy
- Develops and implements safety strategies for developmental and/or marketed programs.
- Manages cross-functional assessments of benefit-risk profiles.
Regulatory Compliance
- Maintains knowledge of current global PV regulations and guidelines.
- Ensures compliance with CIOMS, FDA, PMDA, EMA, ICH, and other applicable regulations.
Qualifications
Basic Qualifications
- 6 years' experience in Drug Safety and Pharmacovigilance.
- Medical Doctor (MD) or internationally recognized equivalent MD.
Preferred Qualifications
- Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
- Proficiency in medical review of ICSRs, coding, and SMQs.
- Experience in authoring and reviewing aggregate reporting, safety surveillance, signal management, and risk management.
