FSP Senior Safety Specialist

Thermo Fisher Scientific • Morrisville, NC

1d • Onsite

About The Position

This role involves monitoring and managing GPS mailboxes, communicating with safety vendors regarding case safety reports, and managing the review of these reports for completeness and quality. The specialist will also handle adverse event reconciliation, collaborate with internal and external parties to gather safety information, and participate in meetings. Key responsibilities include supporting aggregate safety report generation, communicating with business partners about safety information exchange, and contributing to operational meetings as a subject matter expert. The role also requires proactively identifying issues, contributing to process development, and ensuring all activities comply with regulations and controlled procedures. The specialist will perform other assigned tasks as directed by their manager.

Requirements

• Fluent communication in written and spoken English
• Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
• Ability to communicate complex issues in an understandable, effective and relevant manner
• Ability to manage and prioritize a variety of tasks to meet required deadlines
• Ability to solve routine problems with limited supervision and to raise issues constructively
• Ability to deliver high quality documents, including work instructions, guidelines, forms and templates
• Takes ownership of assigned work and manages timelines for deliverables with minimal support
• Ability to make basic operational decisions with an understanding of the impact and potential risk
• Advanced computer skills, including proficiency with Microsoft Office
• Proficiency with safety database systems (i.e. Argus) and MedDRA coding
• 3- 5 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
• Solid experience with the end to end process of safety event collection and reporting
• Relevant experience with the development and submission of aggregate safety reports (e.g. DSUR, PSUR)
• Solid expertise of global (EU/US) pharmacovigilance requirements and practices
• Solid experience with safety database systems (e.g. ARGUS or ArisG) including workflow management

Nice To Haves

• Experience in interaction with 3rd party vendors would be a plus
• Experience with the generation and evaluation of quality metrics would be a plus

Responsibilities

• Regularly monitors and manages GPS mailboxes
• Communicates with safety vendor regarding individual case safety reports (ICSR) and aggregate reports / line listings
• Manages the reviews of ICSRs, listings, tables, and figures for completeness and quality as needed
• Manages (serious) adverse event reconciliation of databases and listings (post marketing and clinical trial sources) as required
• Collaborates with internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) to obtain safety information
• Participates in and takes minutes of meetings as required
• Supports the generation of aggregate safety reports
• Communicates with business partners or distributors regarding the receipt and transmission of safety information as per applicable safety data exchange agreements
• Attends GPS operational meetings and contributes as SME to topics discussed
• Proactively identifies issues and areas for improvement and escalates appropriately
• Contributes to the development of new processes and procedures
• Supports implementation of new processes and systems as required
• Performs all activities in compliance with applicable client Controlled Procedures and with global and local regulations as applicable
• Performs other tasks as assigned by line manager or Head of GPS

Benefits

• Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior