Job description
Job Title: FSP Senior Safety Specialist
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.)
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Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.