Medical Director, Patient Safety
HeadwaySalary not specified
Global Medical Safety Lead(Medical Director) - Remote U.S at Thermo Fisher Scientific
North Carolina, United States
Not SpecifiedCompensation
N/AExperience Level
N/AJob Type
Not SpecifiedVisa
N/AIndustries
Requirements
- Must be legally authorized to work in the United States without sponsorship
- Experience in medical safety data assessment
- Experience in developing and executing safety signaling and benefit-risk management strategies
- Experience collaborating with internal and external stakeholders
- Experience preparing safety sections of regulatory submission documents
- Experience preparing responses to regulatory authority inquiries
- Experience leading the preparation of periodic safety reports (e.g., PSUR, DSUR)
- Experience overseeing the medical assessment of individual case safety reports (ICSR)
- Experience with expedited reporting and unbinding (e.g., SUSAR or urgent safety issues)
- Experience leading or contributing to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
- Experience supporting internal audits and regulatory inspections
- Experience developing and updating Standard Operating Procedures (SOPs)
Responsibilities
- Lead and perform the assessment of medical safety data for assigned products
- Perform safety signal management and benefit risk assessment activities
- Lead cross-functional teams to perform regular reviews of safety data
- Contribute to the development of the overall safety governance structure and activities
- Provide safety strategies and deliver accurate, timely, and high-quality safety contributions for regulatory submissions
- Prepare and/or review safety sections of clinical/regulatory documents
- Provide medical safety support for the preparation of responses to regulatory authority inquiries
- Lead the overall preparation of periodic safety reports (e.g., PSUR, DSUR)
- Oversee the medical assessment of individual case safety reports (ICSR)
- Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
- Support the development of and updates to GPS Standard Operating Procedures (SOPs)
Skills
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
