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
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
NoVisa
Biotechnology, Pharmaceuticals, Clinical ResearchIndustries
Requirements
- Must be legally authorized to work in the United States without sponsorship
- Ideal candidate location is Eastern or Central Time Zone
- Ability to travel 10-20% (international travel may be required)
- Medical background as a physician (implied by Medical Director title and responsibilities)
Responsibilities
- Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
- Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)
- Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
- 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 the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
- Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
- Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
- Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
- Oversee the medical assessment of individual case safety reports (ICSR)
- Confirm criteria and content for expedited reporting and unbinding (e.g. SUSAR or urgent safety issues)
- Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
- Provide medical safety contributions at internal audits and regulatory inspections
- Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this position remote?
Yes, this is a fully remote position based in the United States, with ideal candidate location in the Eastern or Central Time Zone and travel required in a 10-20% range, which may include international.
What are the key responsibilities of this role?
The role involves leading and performing the assessment of medical safety data for assigned products, developing and executing safety signaling and benefit-risk management strategies, and closely collaborating with internal and external stakeholders.
What is the work schedule and travel requirement?
The work schedule is standard Monday-Friday in an office environment, but the position is fully remote with 10-20% travel, which may include international.
What kind of company culture can I expect?
The company encourages partnership, challenging yourself, and contributing to breakthrough solutions in a fast-growing organization focused on innovative treatments for autoimmune diseases, with a strong scientific foundation.
What qualifications make a strong candidate for this role?
Strong candidates should be legally authorized to work in the US without sponsorship, preferably located in the Eastern or Central Time Zone, and have expertise in medical safety leadership, signal management, benefit-risk assessment, and cross-functional collaboration.
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
