Director, Safety Science

6 days ago

Boston, United States KY Innovation Full time

This is what you will do:

The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework

You will be responsible for:

Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:

  • Proven skill set for strategic leadership in a cross functional matrix
  • Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
  • Co-lead activities related to new drug applications and other regulatory filings
  • Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
  • Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation
  • Leading activities to identify and address process gaps
  • Responsible for vendor management and training including budgets
  • Responsible for overall project distribution across therapeutic area
  • As needed represent GPS in global program teams and associated cross functional teams and/or projects
  • Proactively provide guidance and educational training to GPS therapeutic teams
  • Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
  • Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
  • Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians.
  • Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
  • Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products

You will need to have:

  • Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry
  • Knowledge and understanding of US and EU safety regulations pre- and post- marketing
  • Experience with Risk Management and Minimization programs
  • Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans
  • Experience with clinical development including risk/benefit analysis and safety assessment
  • Strong clinical, analytical, problem solving and scientific writing and communication skills
  • 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 an 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.

We would prefer for you to have:

  • Expertise with clinical and safety databases
  • Experience in MedDRA coding and search strategies
  • Excellent, independent judgment based on knowledge and expertise
  • Strong personal time-management and project-management skills
  • Mastery of Microsoft Word, PowerPoint and Excel

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three 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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#LI-EB1

#LI-HYBRID

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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