Medical Advisor, home based
Posted Oct 1, 2021
Neurology and Internal Medicine Center of Excellence
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.
- 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
- Provide strategic input on proposals and protocol considerations on study design in neuroscience and/or Internal Medicine
- Scientific attendance to congress as potential speaker , develop webinars..
- Attend Bid defense, Travel expected
- Board Certified Neuropsychiatrist
- 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
- Pension Plan
- Private Health Insurance
- Paid Time Off
- Work From Home
- Training & Development
- Performance Bonus