Accountable for the staff management and resource allocations in Global Patient Safety
Support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Serve as safety expert on Evidence Generation Team for assigned products
Requirements
MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Experience in the study/research and/or treatment of Oncology disease states
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
safety signal assessmentrisk management planningstatistical analysisclinical study reportingcore safety information development