Senior Manager, Safety Scientist, Global Drug Safety

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:

• Bachelor's 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

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 lack thereof, sex, sexual orientation, 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 provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.