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Open nowFirst seen 4 days ago

FSP Senior Safety Specialist

Lifelancer3,738 open roles

Where
Remote
Work mode
Remote
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Your applicationOpen nowFSP Senior Safety SpecialistLifelancer · Remote

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  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 4 days ago

The posting

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

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.)

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

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