Director, Safety Scientist

AstraZeneca•Boston, MA

8h•$187,000 - $281,000

About The Position

The Director, Safety Scientist serves as a key leader within Global Patient Safety, providing strategic oversight and scientific leadership for the evaluation and management of safety risks across the portfolio. This role involves leading scientific evaluation and management of safety risks, driving proactive safety strategies, ensuring robust benefit-risk assessments, overseeing safety science activities, shaping safety strategy, and leading/coaching a team of Safety Scientists. The position also focuses on promoting consistency in scientific approach, collaborating across functions, and strengthening the organization's overall safety capability.

Requirements

Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
At least 7+ years’ experience in drug safety/pharmacovigilance within the pharmaceutical industry or biotech
Subject matter expertise in global pharmacovigilance regulations, maintaining a strong, up-to-date working knowledge of evolving global requirements
Experience with preparing aggregate safety reports and conducting signal surveillance
Experience with clinical development including risk/benefit analysis and safety assessment
Experience with risk management and minimization programs
Proven skill set for strategic leadership in a cross functional matrix
Strong analytical, problem solving, and scientific writing skills
Demonstrated learning agility and ability to work independently
Sound, independent judgement based on knowledge and expertise
Advanced project leadership with strong organizational and prioritization skills
Strong personal time-management and project-management skills
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Understanding of downstream regulatory, patient, business, and reputational impact of PV actions

Nice To Haves

Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Experience with data visualization tools (e.g., Power BI, Spotfire)
Experience with various roles in drug safety (e.g., case processing, operations)
Mastery of Microsoft Word, PowerPoint and Excel

Responsibilities

Lead and develop a team of safety scientists, drive performance, growth and scientific excellence.
Ensure appropriate resourcing and talent quality across assigned portfolio, including recruitment and team planning.
Lead initiatives for process improvement and cross-departmental process consistency.
Lead implementation of new processes, systems, and ways of working to enhance efficiency and scalability.
Provide oversight of vendors, including management, onboarding and training.
Represent GPS in clinical study teams and cross functional meetings.
Promote and enable cross-functional, proactive and solutions-orientated team actions and behaviors.
Lead workstreams and/or projects with high impact to the business.
Participate as a core member of GPS leadership team.
Set safety team goals aligned to TA and product strategy.
Collaborate with medical directors to lead project-specific safety strategy for assets within the assigned portfolio.
Responsible for the overall scientific and clinical safety content for the assigned portfolio.
Responsible for the implementation and the high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned portfolio.
Provides strategic safety knowledge and support to the safety scientists through initiation, execution, and completion of the clinical programs for the assigned portfolio.
Responsible for the quality of key safety deliverables (e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs)).
Responsible for ensuring compliance and adherence to PV regulations for the assigned portfolio.
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.
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.
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.
Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA).
Maintains a high degree of understanding and awareness of new and emerging clinical safety developments globally.
Maintains strong networks globally; works with international colleagues and with external alliance partners on safety initiatives and regulatory issues.