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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 for highly experienced candidates
- Eligible for discretionary bonus and equity award
- Comprehensive benefits package, including Medical, Dental, and Vision plans
- Unlimited Paid Time Off for exempt employees and generous PTO for non-exempt employees
- Opportunities for career growth within a collaborative and innovative environment
- Flexibility to work remotely based on geographic location
What to Expect (Job Responsibilities):
- Prepare and submit safety reports to global regulatory agencies, ensuring compliance with regulations
- Contribute to the development and improvement of global safety reporting processes
- Collaborate with cross-functional teams to gather and share safety information
- Participate in audits and inspections related to safety reporting
- Assist in the generation and writing of Development Safety Update Reports (DSURs) and other periodic 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 is required
- 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):
- Medical writing experience with Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Safety Data Exchange Agreements (SDEAs)
- Experience with safety database programming, particularly with ARISg
- Oncology experience
#Biotechnology #Pharmacovigilance #DrugSafety #CareerOpportunity #CompetitivePay
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