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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
- Eligible for discretionary bonuses and equity awards
- Comprehensive benefits package including medical, dental, vision, and wellness programs
- Flexible work environment with the option for remote work
- Unlimited Paid Time Off (PTO) for exempt employees and generous vacation and personal days for non-exempt employees
- Opportunities for professional development and growth within a cutting-edge biopharmaceutical company
What to Expect (Job Responsibilities):
- Manage safety issues for global and domestic clinical studies, directing pharmacovigilance team efforts for safety review committees
- Triage and evaluate Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) for regulatory reportability
- Process ICSRs and SAEs in the safety database and prepare for regulatory submission
- Mentor pharmacovigilance staff and ensure data integrity and compliance with regulations
- Implement and optimize pharmacovigilance processes to enhance efficiency and maintain 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 both post-marketing and clinical case processing
- Proficient with medical terminology
- Safety database experience required, preferably with ARISg
- Strong understanding of global Good Clinical Practices (GCPs) and regulatory requirements
How to Stand Out (Preferred Qualifications):
- Medical writing experience with PSURs, DSURs, and SDEAs
- Effective mentoring skills and ability to lead and train others
- Broad-based therapeutic knowledge
- Excellent analytical and technical skills, including data integration from various sources
#Biotechnology #DrugSafety #Pharmacovigilance #CareerOpportunity #RemoteWork
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