Senior Safety Specialist

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

📋 Description

• Continuously oversee and manage GPS mailboxes.

• Liaise with safety vendors concerning individual case safety reports and aggregated reports/listings.

• Supervise reviews of ICSRs, listings, tables, and figures to ensure completeness and quality.

• Oversee serious adverse event reconciliation across post-marketing and clinical trial databases and listings.

• Collaborate with clinical, medical, regulatory, healthcare professionals, consumers, and contracted-resource stakeholders to gather safety information.

• Attend meetings and document minutes as necessary.

• Assist in the creation of aggregate safety reports.

• Communicate with business partners and distributors regarding the receipt and transmission of safety information under applicable data exchange agreements.

• Participate in GPS operational meetings, contributing as a subject matter expert.

• Identify issues and areas for improvement and escalate them appropriately.

• Contribute to the development of new processes and procedures.

• Support the implementation of new processes and systems.

• Conduct activities in accordance with client-controlled procedures and applicable global and local regulations.

• Execute other tasks assigned by the line manager or Head of GPS.

⛳️ Requirements

• Proficient communication in both written and spoken English.

• Advanced understanding of medical terminology, pharmacovigilance processes, and relevant global regulations, including EU, US, and Japan standards.

• Capability to articulate complex issues clearly and effectively.

• Skill in managing and prioritizing tasks to meet deadlines.

• Aptitude for addressing routine problems with minimal supervision and constructively raising issues.

• Capacity to produce high-quality documents, such as work instructions, guidelines, forms, and templates.

• Competence in managing timelines for deliverables with limited support.

• Ability to make basic operational decisions while understanding their impact and potential risks.

• Advanced computer skills, including proficiency in Microsoft Office.

• Familiarity with safety database systems such as Argus or ArisG.

• Proficiency in MedDRA coding.

• Bachelor’s or Master’s degree, or local equivalent, in nursing, healthcare, life sciences, or a relevant field.

• 3–5 years of pertinent experience in global pharmacovigilance/drug safety, including EU and US experience.

• An equivalent and adequate combination of education and experience.

• Strong experience with end-to-end safety event collection and reporting.

• Experience in developing and submitting aggregate safety reports such as DSUR and PSUR.

• Solid expertise in global EU/US pharmacovigilance requirements and practices.

• Significant experience with safety database systems, including workflow management.

• Ability to communicate, receive, and comprehend information and ideas with diverse groups of people.

• Capability to work upright and stationary for standard working hours.

• Proficiency in utilizing and learning standard office equipment and technology effectively.

• Ability to perform successfully under pressure while prioritizing and managing multiple projects or activities.

🏝️ Benefits

• Health and wellbeing support.

• Healthy and balanced work environment.

• May require travel.