Associate Medical/Medical Director - Nephrology

Job Description: Associate/Medical Director, Pharmacovigilance

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

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

Discover Impactful Work:

• 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.
• 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).

A Day in the Life:

General Support:

• Ensures tasks delegated to PVG are properly executed.
• Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Adheres to client SOPs/directives and project specific WPDs for assigned projects.
• Adheres to PPD’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answers all study-related medical questions.
• Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and/or reviews CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete.

Clinical Trial Support:

• 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 (e.g., discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision-making with regard to clinical situations as they relate to the investigational study.
• Provides medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.
• 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.

Marketed Products Support:

• Manages signal detection activities.
• Scientifically reviews aggregate reports.
• Contributes to label updates.
• Supports dossier maintenance and risk management activities.
• Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.).

Company Information

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.