1 month ago
Job type: Full-time
Hiring from: Europe Only
TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.
The Medical Advisor is part of the Project Delivery organization and will work independently on handling of safety/medical issues according to company policies, SOPs and regulatory requirements. The Medical Advisor has the medical expertise, and specifically provides an authoritative opinion and answers medically based questions concerning medical, legal and regulatory matters.
This position can be home/ office based in one of TFS locations in Europe.
- Medical advice on study design and measurements in clinical trials
- Review of the safety section in study protocols and investigators brochure
- Review of safety listings as adverse events, laboratory listings, vital signs and ECG
- Review of clinical trial reports from a safety perspective.
- Medical assessment of AEs, SAEs
- Medical review of individual safety cases, cumulative case listings, PSUR/PBRER, DSUR, Risk Management Plans
- Literature review
- Signal detection
- Medical monitor in clinical trials
- Contribute to department SOPs and tools
- Accompany Commercial Operations colleagues on customer visits and participate in presentations when required
- M.D. Board Certified in Neurology
- 5 years of experience in clinical practice as a physician
- Able to work in a fast-paced environment with changing priorities
- Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
- Excellent written and verbal communication skills
- Experience in Medical Monitoring
- Experience in Neurology or Internal Medicine
- Private Health Coverage
- Corporate Pension Plan
- Life Insurance
- Global General Liability Insurance
- Global Travel Insurance
- Home-based Allowance
- Internet reimbursement
- Flexible working schedule
Before you apply, please check if any restrictions apply in terms of time zone or country.
This job has a geo-restriction in place: Europe Only.
Please mention that you come from Remotive when applying for this job.
Does this job need an edit? 🙈