Senior Manager, Safety Scientist

AstraZeneca • Boston, MA

11d • Hybrid

About The Position

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). The individual will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures.

Requirements

• Bachelor’s degree in a biologic/medical/clinical/nursing field with at least 3 years of 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
• Good judgement
• Ability to interact effectively with people of multiple subject areas 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

Nice To Haves

• Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
• Experience preparing aggregate safety reports and conducting signal surveillance
• Experience with clinical development including risk/benefit analysis and safety assessment
• Expertise with clinical and safety databases
• Experience in MedDRA coding and search strategies
• Strong personal time-management and project-management skills
• Experience with data visualization tools (e.g., Power BI, Spotfire)
• Project leadership, organizational, and prioritization skills

Responsibilities

• 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 leading 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 leading 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 authority 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 solid understanding of evolving global regulations

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior