Senior Manager, Safety Scientist

AstraZeneca•Boston, MA

37d

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

Leading risk management evaluation and resolution for assigned products and projects.
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