Senior Manager, Safety Scientist, Global Drug Safety (Alexion)
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
The Senior Manager Safety Scientist plays a pivotal role within Global Drug Safety to ensure safety assessment for all Alexion products. The Senior Manager Safety Scientist in collaboration with Medical Directors Global Drug Safety are responsible for safety surveillance and risk management activities pertaining to Alexion products.
You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:
Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical Directors
Responsible for project managing and authoring of safety documents including PSUR PBER PADER RMP REMS CSRs and ad hoc requests in collaboration safety physicians.
Authors high quality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirements
Responsible for authoring safety section in collaboration with team members on regulatory responses IBs/CCDS protocol ICF review Data Monitoring Committees reports and requests and other documents and provide the necessary quality control to ensure alignment with core safety position.
Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
Assists GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed
Assists in the evaluation of risk minimization activity
Assist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors.
Supports activities related to new drug applications and other regulatory filings
Contribute to on-going process enhancement for safety analytics and reporting such as developing standard procedures and templates
You will need to have:
Bachelors degree in a biologic/medical/clinical/nursing field
Knowledge and understanding of US and EU safety regulations pre- and post- marketing
Experience with Risk Management and Minimization programs
Experience preparing post marketing safety regulatory documents including PSURs PBRERs and Risk Management Plans
Experience with clinical development including risk/benefit analysis and safety assessment
Strong analytical problem solving and scientific writing and communication skills
The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer you to have:
Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD Nurse Practitioner or PhD with at least 3 years of experience in pharmaceutical industry in drug safety/pharmacovigilance
Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Date Posted
25-lis-2025Closing Date
31-gru-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.
Required Experience:
Senior Manager
Key Skills
- Quality Assurance
- Construction Experience
- Food Safety Experience
- Management Experience
- Root cause Analysis
- Risk Analysis
- OSHA
- EPA
- HACCP
- Product Development
- EHS
- Manufacturing
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
