Thermo Fisher Scientific

FSP Senior Safety Specialist

Thermo Fisher Scientific$95K — $115K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's degree in nursing, healthcare, life-science or relevant field
  • 3-5 years of relevant experience in global pharmacovigilance/drug safety
  • Solid experience in safety event collection and reporting
  • Expertise in EU/US pharmacovigilance requirements and practices
  • Experience with safety database systems (e.g. ARGUS, ArisG)

Responsibilities

  • Monitor and manage GPS mailboxes regularly
  • Communicate with safety vendors regarding safety reports
  • Review ICSRs, listings, tables, and figures for quality
  • Reconcile databases and listings for serious adverse events
  • Collaborate with clinical, medical, and regulatory teams for safety information
  • Generate aggregate safety reports
  • Identify issues and propose process improvements

Benefits

  • Health and wellness support
  • Encouragement of a balanced work environment
  • Opportunity to thrive in a supportive workplace
  • Potential for travel to engage with external parties
Full Job Description
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.)

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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