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Safety Scientist (Client Embedded) - Remote

8+ years
Not Disclosed
10 May 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Scientist II (Client Embedded)
Company: Thermo Fisher Scientific
Experience: 8+ years
Location: Remote

Job Description Summary:
Thermo Fisher Scientific seeks a Safety Scientist II to manage the safety profile of new drugs in clinical trials, oversee case-processing activities, and perform regulatory reporting and medical monitoring tasks.

Job Description:

Responsibilities:

  • Plan, coordinate, and deliver signal detection and product safety scientist activities.
  • Mentor junior colleagues and develop processes/tools/systems.
  • Serve as lead on smaller FSP-type projects.
  • Conduct quality review for signal detection and product safety scientist tasks.
  • Advise clients on safety-related issues.
  • Support training and mentoring of junior colleagues.
  • Ensure tasks are conducted in accordance with company policies, contractual agreements, and regulations.
  • Participate in departmental initiatives and serve as a subject matter expert.
  • Lead project implementation and coordination for assigned projects.
  • Resolve complex issues using professional concepts and company objectives.
  • Determine methods and procedures on new assignments and coordinate activities of other personnel.

Keys to Success:
Education and Experience:

  • Bachelor's degree.
  • Previous experience equivalent to 8+ years.

Knowledge, Skills and Abilities:

  • Expertise in pharmacovigilance requirements for marketed products and clinical trials.
  • Excellent attention to detail, data interpretation, and medical-scientific writing skills.
  • Advanced critical thinking and problem-solving skills.
  • Solid project management skills with the ability to manage multiple projects simultaneously.
  • Ability to motivate, mentor, and provide guidance to less experienced staff.
  • Proficiency in complex project administration, including budget activities and forecasting.
  • Excellent oral and written English language communication skills.
  • Advanced computer skills, including proficiency in Microsoft Office products.
  • Ability to maintain a positive and professional demeanor in challenging circumstances.
  • Ability to work effectively within a team to attain a shared goal.

About Thermo Fisher Scientific:
Thermo Fisher Scientific enables customers to make the world healthier, cleaner, and safer through research, development, and delivery of life-changing therapies.

Application:
Apply today at Thermo Fisher Scientific Careers

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and values diversity in its workforce.