Senior Manager, Safety Scientist

Job Description

This is what you will do:

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:

• Participating in ongoing safety data review and analysis for products in designated therapeutic areas
• Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical Directors
• Project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians
• Authoring high quality aggregate safety reports to meet regulatory and internal deadlines; ensuring all safety regulatory documents are processed and submitted according to regulatory requirements
• 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 providing the necessary quality control to ensure alignment with core safety position
• Managing portfolio of products/projects related to risk management; assisting Safety Physicians in the development of risk management strategy and activities for assigned products
• Assisting GDS Medical Directors to evaluate and oversee risk minimization activities including tracking of activities as needed
• Assisting with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors
• Supporting activities related to new drug applications and other regulatory filings
• Contributing 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 for 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
• Excellent, independent judgment based on knowledge and expertise
• Strong personal time-management and project-management skills
• Mastery of Microsoft Word, PowerPoint and Excel

Expectation of working in the office 3 days a week: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.