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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
- Eligible for discretionary bonuses and equity awards
- Comprehensive benefits package including medical, dental, and vision options
- Opportunities for professional development and career advancement
- Flexible work environment with options for remote work
- Supportive company culture focused on employee well-being
What to Expect (Job Responsibilities):
- Manage safety issues for global and domestic clinical studies and direct pharmacovigilance team efforts
- Triage and evaluate individual case safety reports (ICSRs) and serious adverse events (SAEs) for completeness and regulatory reporting
- 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 for efficiency and regulatory compliance
What is Required (Qualifications):
- RN, Pharmacist, BS, or BA degree in Health Sciences or 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
- Experience with safety databases, particularly ARISg
- Excellent oral and written communication skills
How to Stand Out (Preferred Qualifications):
- Medical writing experience with Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
- Strong knowledge of Good Clinical Practices (GCPs) and regulatory requirements
- Effective problem-solving and project management skills
- Ability to coordinate complex global and domestic studies
- Experience in mentoring and training others
#Biotechnology #Pharmacovigilance #DrugSafety #CareerOpportunity #RemoteWork
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