Director, Safety Scientist, GDS

Company: Alexion Pharma Spain S.L.
Location: Boston
Posted on: May 28, 2023

Job Description:

Some opportunities happen only once in a lifetime - like a job where you have the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework
You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:

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• Proven skill set for strategic leadership in a cross functional matrix
  
• Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
  
• Co-lead activities related to new drug applications and other regulatory filings
  
• Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
  
• Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation
  
• Leading activities to identify and address process gaps
  
• Responsible for vendor management and training including budgets
  
• Responsible for overall project distribution across therapeutic area
  
• As needed represent GPS in global program teams and associated cross functional teams and/or projects
  
• Proactively provide guidance and educational training to GPS therapeutic teams
  
• 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 GPS Medical Directors
  
• Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians.
  
• 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
  
  You will need to have:
  
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  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry
    
  • 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 clinical, 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 for you to have:
    
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    • Expertise with clinical and safety databases
      
    • Experience in MedDRA coding and search strategies
      
    • Excellent, independent judgment based on knowledge and expertise
      
      
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      • Strong personal time-management and project-management skills
        
      • Mastery of Microsoft Word, PowerPoint and Excel
        
        Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be found at:.
        Alexion 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 status,pregnancy, (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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding a legally required exemption or accommodation, please contact .Alexion participates in E-Verify.
        As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
        AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click.

Keywords: Alexion Pharma Spain S.L., Boston , Director, Safety Scientist, GDS, Executive , Boston, Massachusetts