Senior Submissions Officer

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist clients with all facets of safety submissions.

• Aid the Submission Manager in the development, documentation, implementation, and upkeep of submission processes and standards.

• Keep abreast of global regulatory reporting requirements to guarantee compliance.

• Execute submissions of Individual Case Safety Reports (ICSRs) and aggregate reports to relevant parties.

• Conduct ICSR exchanges with relevant parties in accordance with applicable documentation.

• Offer support for pharmacovigilance operations linked to safety reporting.

• Carry out quality control of ICSR reportability assessments.

• Oversee quality control of daily safety submission activities.

• Engage in training and maintain as well as develop quality system documents for the Safety Reporting domain.

• Mentor junior team members.

• Serve as a subject matter expert on submissions during audits and inspections, representing submission business processes and standards.

⛳️ Requirements

• Graduate in life sciences, pharmacy, nursing, or another healthcare-related field.

• 3–5 years of experience in pharmacovigilance.

• Minimum of 2 years of experience in submissions.

• Strong organizational skills, including attention to detail and the ability to multitask.

• Management abilities, encompassing time and issue management.

• Excellent communication skills, ensuring clear and effective interaction with both internal and external stakeholders.

• Proficiency in English, both spoken and written.

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for growth.

• A collaborative and supportive team culture.

• Training opportunities available.

• A workplace focused on belonging.

• Chance to contribute to patient safety and global pharmaceutical treatments.