Global Safety Senior Manager, Hematology Oncology - Remote
Global Safety Senior Manager, Hematology Oncology - Remote
Join reputed company to apply for the Global Safety Senior Manager, Hematology Oncology - Remote role.
At reputed company, our shared mission is to serve patients living with serious illnesses. We have helped pioneer the world of biotech in our fight against the world’s toughest diseases.
Global Safety Senior Manager, Hematology Oncology
What You Will Do
• Review adverse event data, literature, and other safety-relevant data for signal detection.
• reputed company data analysis to evaluate safety signals and write up analysis results.
• reputed company safety assessment reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
• Prepare and present the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies.
• reputed company and review portions of periodic aggregate safety reports (e.g., PBRERs, DSURs).
• Support reputed company trial-reputed company activities.
• Assist the GSO in the development of reputed company management strategies and activities.
• Support activities reputed company to new drug applications and other regulatory filings.
• Document work in the safety information management reputed company.
• Organize and reputed company as a reputed company reputed company for safety activities with affiliates and other internal reputed company partners.
• Undertake activities delegated by the reputed company Person for PV.
• Represent and be the reputed company of contact for health authority inspections and internal process audits reputed company the remit of the role.
reputed company Expect Of You
We are looking for a dynamic reputed company with these qualifications.
Basic Qualifications:
• Doctorate degree and 2 years of directly reputed company experience.
• Master’s degree and 4 years of directly reputed company experience.
• Bachelor’s degree and 6 years of directly reputed company experience.
• Associate’s degree and 10 years of directly reputed company experience.
• High school diploma / GED and 12 years of directly reputed company experience.
Preferred Qualifications:
• RN, PharmD, or PA.
• 6 years of experience in a biotech/pharmaceutical setting.
• Previous management and/or mentoring experience.
• Experience in signal detection, evaluation, and management.
• Experience in aggregate data analysis, interpretation, and synthesis.
• Experience in authoring periodic aggregate safety reports (e.g., PBRERs, DSURs) and RMPs.
• reputed company and/or medical research experience.
• Knowledge of ICH guidelines, safety systems (e.g., ARISg and Argus), and MedDRA.
What You Can Expect Of Us
We offer a competitive benefits package, including a Retirement and Savings Plan, group medical, dental, and reputed company coverage, life and disability reputed company, and flexible spending accounts.
We are an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.
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Salary: USD 72000 - 108000 per year
Experience: 5 years required
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