NantHealth
Senior Specialist, Drug Safety Submissions
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Job Description
- Req#: R2728
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $148,500 annually for highly experienced candidates
- Eligible for discretionary bonuses and equity awards
- Comprehensive benefits package including medical, dental, and vision plans
- Opportunities for professional development and career growth
- Flexible work environment with options for remote work
- Supportive company culture focused on employee wellbeing
What to Expect (Job Responsibilities):
- Prepare and submit safety reports to global regulatory agencies
- Ensure submissions comply with global regulations and guidelines
- Collaborate with cross-functional teams to gather and share safety information
- Participate in audits and inspections related to safety reporting
- Assist with clinical study project setup and close-out regarding regulatory reporting
What is Required (Qualifications):
- RN, pharmacist, or Bachelor’s degree in Health Sciences with 5+ years of relevant experience, or Associate’s degree with 7+ years of experience
- Experience in drug safety, pharmacovigilance, and global regulatory reporting
- Proficiency in using safety databases and reporting systems
- Strong understanding of pharmacovigilance principles and global regulatory requirements
- Excellent oral and written communication skills with attention to detail
How to Stand Out (Preferred Qualifications):
- Experience with safety database programming, particularly ARISg
- Medical writing experience with PSURs, DSURs, and SDEAs
- Oncology experience
#Biotechnology #DrugSafety #Pharmacovigilance #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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