Associate Director, Safety Scientist

The Associate Director, Safety Scientist plays a pivotal role within Global Patient Safety, providing strategic leadership and project management to proactively evaluate and manage safety risks in close collaboration with 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:

Leading 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

Leading the 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

Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA)
Mentoring, 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 5+ year experience in pharmaceutical industry in drug safety/pharmacovigilance

Subject matter expertise in global pharmacovigilance regulations Experience preparing aggregate safety reports and conducting signal surveillance

Experience with clinical development including risk/benefit analysis and safety assessment

Strong analytical and problem-solving skills

Excellent communication and interpersonal skills

Strong scientific writing skills

Demonstrated learning agility and ability to work independently

Ability to apply decision-making principles to contribute to key scientific/clinical discussions

Sound, independent judgement based on knowledge and expertise

Ability to interact effectively with colleagues of multiple disciplines…