Clinical Trial Safety/Pharmacovigilance Specialist - Population Health Science & Policy

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

Roles & Responsibilities:
The Clinical Trial Safety/Pharmacovigilance Specialist will triage adverse events as they are reported by clinical centers and work with key safety team members. The specialist supports the departmental and field activities for the conduct of clinical research studies in compliance with applicable regulatory standards, IRB policies and procedures and internal requirements. He/she will provide a role in the management and oversight of clinical adverse event reporting, compliance with all regulatory requirements and in verifying data from multi-center clinical trials. The incumbent will work collaboratively with the clinical trial monitors. He/she will report directly to the Director of Regulatory and Administrative Affairs with whom he/she will collaborate on the responsibilities for all safety reporting activities and verification of safety data collection for grant-funded and industry-funded clinical trials.  Specific duties are listed below:
  • Under the supervision of the Director of Regulatory and Administrative Affairs, the Clinical Trial Safety/Pharmacovigilance Specialist will have the following responsibilities: 
  • Supervise adverse event reporting, source documentation collection and adjudication processes in compliance with clinical trial protocols and regulatory guidelines and policies.
  • Triage source documents such that duplicative and extraneous source records are removed from the source documentation provided to the medical monitors; 
  • Request and track additional source documents as needed; 
  • Perform quality control review of completed assessments, working closely with the current staff to ensure that all expedited adverse event reporting is handled efficiently and effectively.
  • Independently schedule and maintain site contact. 
  • Keep supervisor informed of changes in work schedule and/or workload and communicate schedule to study management.
  • Will assist with data management activities for clinical study activities including, but not limited to, Event Adjudication Committee meetings, Data and Safety Monitoring Board meetings and publication activities as required.
  • Participate in regular teleconferences, staff meetings, etc.
  • Assist with compilation of device and/or product accountability as necessary.
  • Assist with study closure activities and conduct study close out visits.
  • Develop educational and research training program to enhance knowledge base within Mount Sinai and for use in multi-center clinical trials 
  • Strong interpersonal skills. Attention to detail required. 
  • Must possess the ability to work in a dynamic fast-paced environment. 
  • Must be able to work independently within the scope of a team environment. Previous clinical research related experience required. 
  • Experience working in an academic environment required. 
  • Experience in clinical trial adverse event reporting required. BSN/RN/MPH/DPharma degree preferred. 
  • Cardiovascular and/or critical care clinical experience ideal. 
  • Familiarity with web-based data collection systems and proficiency in MS Office software highly desirable. 
Strength Through Diversity

The Mount Sinai Health System believes that diversity and inclusion is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize healthcare delivery together.
We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care. 

Explore more about this opportunity and how you can help us write a new chapter in our story! 

Who We Are

Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation. 

EOE Minorities/Women/Disabled/Veterans


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