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Drug Safety Reporting Senior - Remote

1-8 years
Not Disclosed
15 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 Reporting Manager

Company: Thermo Fisher Scientific

Location: Remote

Overview: At Thermo Fisher Scientific, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. As a Safety Reporting Manager, you will play a crucial role in overseeing the planning, coordination, and delivery of safety reporting for large and complex projects. You'll lead projects, ensuring compliance, financial stability, and quality, while providing support to team members and acting as the primary point of contact in the absence of the manager.

Key Responsibilities:

  1. Receive, prepare, and submit safety reports to relevant parties, ensuring compliance at all stages.
  2. Identify and resolve quality or timeline issues, keeping the Manager informed of progress.
  3. Lead and monitor large and complex projects to ensure successful and timely completion.
  4. Attend and present at meetings as required.
  5. Facilitate and advise on company, client, and regulatory audits.
  6. Provide training, support, and mentorship to team members.
  7. Collaborate with the manager to analyze compliance metrics and recommend updates to financial systems.

Requirements:

  • Education: Bachelor's degree.
  • Experience: 8+ years of relevant experience or equivalent combination of education and experience.
  • Skills and Abilities:
    • Advanced knowledge of medical terminology.
    • Proficiency in Microsoft Office and database functionality.
    • Thorough understanding of global safety reporting requirements and procedural documents.
    • Strong critical thinking and problem-solving abilities.
    • Demonstrated leadership skills and ability to motivate others.
    • Effective collaboration in a team environment.
    • Attention to detail with the ability to navigate ambiguity and complexity.
    • Initiative and ability to persuade and negotiate tasks.
    • Excellent communication skills to assist internal clients effectively.

Company Values: Thermo Fisher Scientific values Integrity, Intensity, Innovation, and Involvement. As part of a diverse team of over 100,000 colleagues, you'll work together to accelerate research, solve scientific challenges, drive innovation, and support patients in need.

How to Apply: Apply online at http://jobs.thermofisher.com.

Equal Opportunity Employer: 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.

Accessibility/Disability Access: Thermo Fisher Scientific offers accessibility services for job seekers requiring accommodations in the application process. Job seekers with disabilities requiring assistance should contact 1-855-471-2255.