Medical Advisor
Job Overview
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Medical Advisor
About this role
As part of our Strategic Resourcing Solutions (SRS) team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
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.
Key Responsibilities:
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.
Contribute to proposals for new work and attend bid defense meetings.
Accompany Commercial Operations colleagues on customer visits and participate in presentations when required
Qualifications:
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
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.
Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.
#Together we make a difference