Senior Manager, Safety Scientist Full-time NEW

Senior Manager, Safety Scientist

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.

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

Required skills and experience:

• 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

Desirable skills:

• 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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $132,873 to $199,310. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At AstraZeneca's Alexion division, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio and an entrepreneurial spirit, you'll be part of a team that values connection and collaboration. We empower our employees through tailored development programs that align personal growth with our mission. Join us in driving change with integrity while celebrating diversity and innovation.

Ready to make a difference? Apply now to join our team at Alexion!