Drug Safety Specialist (Night Shift)

Lensa; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Join a dynamic team at Thermo Fisher Scientific as a Safety Specialist, ensuring high safety standards in Pharmacovigilance. This role will involve daily pharmacovigilance activities, including regulatory reporting and case reviews, within a supportive and innovative environment. We seek individuals with strong communication, critical thinking, and attention to detail to drive our mission forward.

Benefits

Dynamic work environment

Commitment to technological innovation

Qualifications

• Proven experience in Pharmacovigilance or related field.
• Strong understanding of pathophysiology and disease process.
• Ability to manage and prioritize tasks under limited supervision.

Responsibilities

• Perform day-to-day pharmacovigilance activities, including quality case reviews.
• Prepare regulatory safety reports and assist with project implementation.
• Mentor less experienced staff on best practices.

Skills

Critical Thinking

Problem Solving

Good Communication Skills

Attention to Detail

Education

Experience in Pharmacovigilance

Tools

Microsoft Office

Database Management

Job description

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About the Role

Join Thermo Fisher Scientific Inc. as a Safety Specialist in a dynamic team. Contribute to maintaining high safety standards in Pharmacovigilance.

Responsibilities

• Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
• Prepares and maintains regulatory safety reports.
• Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.
  
  

Job Complexity

• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  
  

Job Knowledge

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
  
  

Supervision Received

• Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercise judgment within defined procedures and practices to determine appropriate action.
  
  

Business Relationships

• Contacts are primarily internal to the company with infrequent external customer/vendor contact on routine matters. Builds productive internal/external working relationships.
  
  

Requirements

• Proven experience in Pharmacovigilance or a related field.
• General understanding of pathophysiology and the disease process
• Detailed knowledge of relevant therapeutic areas as required for processing AEs
• Strong critical thinking and problem solving skills
• Good oral and written communication skills including paraphrasing skills
• Good command of English and ability to translate information into local language where required
• Computer literate with the ability to work within multiple databases
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
• Understanding the importance of and compliance with procedural documents and regulations
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Strong attention to detail
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team to attain a shared goal
  
  

Why Join Us?

At Thermo Fisher Scientific, we provide a dynamic and inclusive work environment where your contributions are valued. We are committed to driving technological innovation and supporting patients in need. Join our team and assist us in successfully implementing solutions that have a global impact.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  IT Services and IT Consulting

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