Drug Safety Reporting Senior

8+ years

Not Disclosed

Remote, USA

12 May 21, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Reporting Project Manager

Company: Thermo Fisher Scientific

Location: Remote

About Us:

At Thermo Fisher Scientific, we empower our employees to make a global impact. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Our work spans laboratory, digital, and decentralized clinical trial services, driven by our PPD clinical research portfolio. Join us in improving health outcomes worldwide.

Job Purpose:

The Safety Reporting Project Manager is responsible for planning, coordinating, and delivering safety reporting for large and complex projects. This role involves full project oversight, including metrics, compliance, and finances. The Project Manager will provide training and support to team members and serve as the primary point of contact in the absence of the manager.

Key Responsibilities:

Safety Reporting:
- Receive, prepare, and submit safety reports to applicable parties, ensuring compliance at all stages.
- Identify and resolve quality or timeline issues, keeping the manager informed of progress.
- Lead and monitor large, complex projects to ensure successful and timely completion.
Project Management:
- Develop project plans and manage timelines for safety reporting.
- Recommend updates to procedures and participate in regulatory intelligence activities.
- Attend and present at various meetings as required.
Team Support:
- Provide training and support to lower-level team members.
- Mentor new starters and provide input on individual performance.
- Facilitate and advise on company, client, and regulatory audits as needed.
Reporting and Metrics:
- Work with the manager to collate metrics and analyze compliance.
- Provide recommendations on updating financial systems.

Qualifications:

Education:
- Bachelor's degree in a relevant field.
Experience:
- Minimum of 8 years of relevant experience or an equivalent combination of education, training, and experience.
Skills and Abilities:
- Advanced knowledge of medical terminology.
- Excellent Microsoft Office skills and understanding of database functionality.
- Thorough understanding of global safety reporting requirements.
- Strong critical thinking and problem-solving abilities.
- Demonstrated leadership, mentoring, and motivational skills.
- Strong attention to detail and ability to work with ambiguity.
- Ability to work collaboratively within a team environment.
- Excellent communication, persuasion, and negotiation skills.

Why Thermo Fisher Scientific:

Join a team of over 100,000 colleagues united by common values: Integrity, Intensity, Innovation, and Involvement.
We offer diverse experiences, backgrounds, and perspectives, working together to accelerate research, solve scientific challenges, drive technological innovation, and support patients in need.

Application Information:

Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer.

Accessibility/Disability Access:

If you require accessibility assistance or an accommodation to apply, please call 1-855-471-2255*. Include your contact information and specific details about your required accommodation.

Contact:

For more information, visit our website: Thermo Fisher Scientific Careers

*This telephone line is reserved for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes will not receive a response.

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Drug Safety Reporting Senior

Job Description

Job Title: Safety Reporting Project Manager

Company: Thermo Fisher Scientific

Location: Remote

About Us:

Job Purpose:

Key Responsibilities:

Qualifications:

Why Thermo Fisher Scientific:

Application Information:

Accessibility/Disability Access:

Contact:

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