The Senior Manager, Safety Scientist plays a pivotal role within Global Patient Safety to actively evaluate and manage safety risks in close collaboration with the GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). You will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures. You will report to the Director, Safety Scientist, GPS and be based in Boston, MA.
You will be responsible for:
Contributing to safety data reviews and analyses for products in designated therapeutic areas
Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
Ensuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)
Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.
Authoring and project management of health authority queries
Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
Assisting GPS Medical Directors in the development of risk management strategy
Training and/or managing junior safety scientists and fellows
Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels
Assisting Global Safety Physicians in developing a strategy for safety-related regulatory activities
Proactively managing safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines Supporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templates
Representing global patient safety as a subject matter expert in clinical study teams and cross-functional meetings
Contributing to initiatives for process improvement and cross-departmental process consistency
Maintaining a strong, up-to-date working knowledge of evolving global regulations
You will have:
Bachelor’s degree in a biologic/medical/clinical/nursing field
At least 3 years' experience in drug safety/pharmacovigilance
Knowledge of global pharmacovigilance regulations
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Strong scientific writing skills
Demonstrated learning agility and ability to work independently
Sound judgement
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Basic understanding of downstream regulatory, patient, business, and reputational impact of PV actions
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 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 have:
Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
Experience…