Provide medical oversight of surveillance activities, safety signal decisions and risk management actions
Monitor safety activities for impact to Core Safety Information and Core Risk Minimization activities
Build collaborative working relationships to ensure full cooperation
Represent GPS Medical for both internal and external stakeholders regarding a product or developmental therapeutic agent
Responsible for the oversight of regulatory queries on safety-related topics
Responsible for appropriate implementation of PSA/HHE process
Requirements
Medical Doctor or Doctor of Osteopathy
Board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
Minimum 5+ years' experience in the pharmaceutical industry or clinical care setting
Oncology/Hematology preferred
Clinical development or pharmacovigilance or medical affairs experience preferred
Knowledge of drug development process
Fluent in English with highly effective written and verbal communication skills
Strong clinical/diagnostic skills
Benefits
Comprehensive benefit program including:
Medical, dental, vision and prescription drug benefits
Vacation benefits
Eligibility to participate in a company-sponsored 401(k)
Pension
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)