Associate Director Safety Scientist Global Patient Safety

This is what you will do:

The Associate Director SafetyScientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and crossfunctional team members within the global regulatory framework

You will be responsible for:

• Managing safety scientist activities across multiple product portfolios and/or indications
• Organizing training and/or supporting junior safety scientists and fellows

• Supporting activities related to new drug applications and other regulatory filings

• Representing global patient safety at regulatory inspections e.g. MHRA FDA EMA etc.
• Leading gap analysis to ensure alignment with changes in global regulations
• Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy
• Representing GPS in global program teams and associated cross functional teams and/or projects as needed
• Proactively providing guidance and educational training to GPS therapeutic teams
• Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
• Performing Signal Surviellance activities for respective programs in collaboration with GPS Medical Directors
• Project managing and authoring of safety documents including PSUR PBER PADER RMP REMS CSRs and ad hoc requestsin collaboration with GPS Medical Directors
• Authoring safety sections in collaboration with team members on regulatory responses IBs/CCDS protocols ICFs Data Monitoring Committee 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 GPS Medical Directors in the development of risk management strategy and activities for assigned products
• Contribute to ongoing process enhancement for safety analytics and reporting such as developing standard procedures and templates
• Assisting GPS Medical Directors to oversee risk minimization activities including tracking of activities as needed
• May be directed by the line function to support initiatives outside of their projects

You will need to have:

• Bachelors degree in a biologic/medical/clinical/nursing field
• Extensive 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
• Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
• Expertise with Microsoft Word PowerPoint SharePoint and Excel
• The duties of this role are generally conducted in an office environment. As is typical of an officebased 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 nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD Nurse Practitioner or PhD
• Expertise with clinical and safety databases
• Experience in MedDRA coding and search strategies
• Excellent independent judgment based on knowledge and expertise
• Strong personal timemanagement and projectmanagement skills
• Mastery of Microsoft Word PowerPoint and Excel

Date Posted

Closing Date

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 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 EVerify.