Senior Submissions Officer
Skills
About the role
This is a senior pharmacovigilance submissions role at PrimeVigilance, handling safety report submissions for pharmaceutical clients, based in Raleigh, NC. You'll manage ICSR and aggregate report submissions to regulatory parties and support quality control across the submissions function. The role also involves mentoring junior team members and acting as a subject matter expert during audits.
What you’ll do
- Support the client in all aspects of safety submissions
- Support the Submission Manager in developing and maintaining submission processes and standards
- Perform submissions of ICSRs and aggregate reports to concerned parties
- Perform exchanges of ICSRs with concerned parties per applicable documents
- Provide support across PV operations tied to safety reporting
- Perform quality control of ICSR reportability assessments and daily submission activities
- Participate in training and maintain quality system documents
- Train junior team members
- Act as subject matter expert for submissions in audits and inspections
What they’re looking for
- Life science, pharmacy, nursing or other healthcare-related degree
- 3-5 years of pharmacovigilance experience, including at least 2 years on submissions
- Strong organization skills including attention to detail and multitasking
- Time and issue management skills
- Clear communication with internal and external stakeholders
- Fluent English, spoken and written
Questions about this role
How many years of experience do I need?
3-5 years of pharmacovigilance experience, including at least 2 years working on submissions.
Do I need a degree?
A life science, pharmacy, nursing or other healthcare-related qualification is required.
Is fluent English required?
Yes, fluent spoken and written English is required.
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