FSP Senior Safety Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

• 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

Knowledge, Skills, and Abilities

• 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

Education and Experience

• Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
• 3- 5 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
• Equivalent and adequate combination of education and experience
• 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
• Experience in interaction with 3rd party vendors would be a plus
• Experience with the generation and evaluation of quality metrics would be a plus

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. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)