Associate Medical Director / Medical Director - Rheumatology / Dermatology

Associate Medical Director / Medical Director - Rheumatology / Dermatology

Work Schedule : Standard (Mon‑Fri)

Location / Division Specific Information : Must be able to pass a comprehensive background check, which includes a drug screening.

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Our detailed, goal‑oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case‑processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with beginning‑to‑end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.

Responsibilities

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
• Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members, and supports business development activities.
• Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
• Ensures tasks delegated to PVG are properly executed, adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un‑blinding requests) of clinical studies.
• Discusses all medical concerns with principal investigators and clients, uses proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and / or full safety data to assess for potential safety concerns.
• Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.

Qualifications

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward‑thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEOffirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Solicitar ahora Guardar trabajo.

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