NantHealth
Senior Drug Safety Specialist
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Job Description
- Req#: R2729
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $148,500 for highly experienced candidates
- Eligibility for discretionary bonuses and equity awards
- Comprehensive benefits package, including medical, dental, vision, and wellness programs
- Opportunities for professional development and mentorship within a collaborative team
- Flexible work environment with the option for remote work
- Commitment to diversity and equal opportunity in the workplace
What to Expect (Job Responsibilities):
- Manage safety issues for global and domestic clinical studies, directing team efforts for safety review committees and Drug Safety Monitoring Boards
- Triage and evaluate data for individual case safety reports (ICSRs) and serious adverse events (SAEs) for completeness and regulatory reportability
- Process ICSRs and SAEs in the safety database and prepare narratives for regulatory submission
- Mentor and train pharmacovigilance team members, ensuring data integrity and compliance with regulations
- Implement and optimize pharmacovigilance processes to enhance efficiency and regulatory compliance
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 post-marketing and clinical case processing
- Proficiency in medical terminology
- Required experience with safety databases (preferably ARISg)
- Strong knowledge of GCPs and regulatory requirements
How to Stand Out (Preferred Qualifications):
- Medical writing experience with PSURs, DSURs, and SDEAs
- Strong command of global pharmacovigilance requirements
- Effective problem-solving and project management skills
- Experience coordinating complex global and domestic studies
- Excellent analytical and technical skills in integrating scientific data
#Biotechnology #Pharmacovigilance #DrugSafety #CareerOpportunity #FlexibleWork
"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. 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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