NantHealth
Senior Specialist, Drug Safety
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Job Description
- Req#: R2800
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $148,500 annually for highly experienced candidates
- Opportunity for career advancement and professional development within a growing company
- Flexible work environment with options for remote work
- Comprehensive benefits package including medical, dental, vision, and wellness programs
- Discretionary bonus and equity award eligibility
- Supportive and collaborative team culture focused on transforming patient lives
What to Expect (Job Responsibilities):
- Manage safety issues for global and domestic clinical studies and lead drug safety team efforts
- Triage and evaluate individual case safety reports (ICSRs) and serious adverse events (SAEs) for regulatory compliance
- Process ICSRs and SAEs, including writing narratives and preparing submissions for regulatory agencies
- Mentor and provide guidance to pharmacovigilance staff while ensuring data integrity and compliance
- Implement and optimize pharmacovigilance processes to enhance efficiency and adherence to global regulations
What is Required (Qualifications):
- RN, Pharmacist, BS or BA degree in Health Sciences or a related field, with 5+ years of drug safety surveillance and/or pharmacovigilance experience
- Experience with both post-marketing and clinical case processing
- Safety database experience required, preferably with ARISg
- Expert knowledge of Good Clinical Practices (GCPs) and global pharmacovigilance requirements
- Excellent oral and written communication skills with strong attention to detail
How to Stand Out (Preferred Qualifications):
- Proficient with medical terminology
- Medical writing experience with PSURs, DSURs, and SDEAs
- Effective mentoring and project management skills
- Knowledge of international safety reporting processes
- Broad-based therapeutic knowledge
#Biotechnology #Pharmacovigilance #CareerOpportunity #RemoteWork #HealthcareBenefits
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
NantHealth, a member of the NantWorks ecosystem of companies, is a next-generation, evidence-based, personalized healthcare company enabling improved patient outcomes and more effective treatment decisions for critical illnesses. NantHealth‘s unique sy...
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