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.

• 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

• 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 and cultures both within and outside the company on a global basis
• Understanding of the 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.

• Advanced degree in a biologic/medical/clinical/nursing field preferred:
  Pharmacist/PharmD, Nurse Practitioner or PhD
• Expertise with clinical and safety…