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Senior Director North America, Global Patient Safety - Jobs in Mississauga

AstraZeneca PLC
Job LocationMississauga
EducationNot Mentioned
SalaryNot Mentioned
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent

Job Description

Role Profile: Senior Director North America, Global Patient SafetyLocation: Onsite with flexibility in Wilmington, Delaware or Mississauga CanadaJob Capsule:This role will lead the strategy, development and delivery of Patient Safety activities and standards across North America (US and Canada).What You Will Do:For given region, develop, support and drive excellence in pre-submission and post-approval pharmacovigilance activities related to AstraZeneca and Alexion products. This role represents the Primary point of safety contact for North America and maintains an effective governance structure to ensure oversight of safety activities. This includes requirements outlined in safety data exchange agreements.Typical Accountabilities:

  • For given Region drives local input into Patient Safety risk management activities and ensures these are implemented and tracked appropriately.
  • Supports the development of team members and the broader safety organization.
  • Supports and where required leads GVP audits and inspections.
  • Ensures strong relationships with country safety leads to maximize opportunities for Patient Safety and AZ/Alexion products.
  • Act as deputy for the local safety manager, supporting activities under their responsibility and providing cover as required.
  • Ensures identification and assessment of risks related to regional pharmacovigilance activities. Communicates and escalates risks to Global Patient Safety and cross functional colleagues as appropriate.
  • Ensures there is business continuity for Patient Safety activities within the region.
  • Responsible for ensuring CAPAs related to safety activities in the Region are appropriate to the issue concerned and closed on time.
  • Maintains a thorough understanding of global and local PV requirements that relate to the local safety officer role.
  • Completes assigned training and maintains personal training records.
  • Promotes and implements continuous improvement activities to optimize productivity and quality.
  • Perform oversight of marketing activities to ensure any solicitation/collection of PV information (e.g. in market research programs; clinical study or registry; internet sites; social media) meets AstraZeneca standards and processes and conforms to the terms of a PVA/SDEA with a third party.
  • Maintains a high degree of understanding and awareness on new Patient Safety trends and developments.
  • Ensures budget oversight for the Region.
Required Education, Experience and Skills:
  • Bachelors degree or equivalent healthcare professional qualification
  • A minimum of 5+ years experience working in Patient Safety within one or more countries
  • Expert knowledge of patient safety regulations and the expectations of Regulatory Authorities
Preferred Education, Experience and Skills: .
  • Expert reputation within the business and industry
  • Experience working in Patient Safety in an above-country role
  • Good knowledge of FDA and Health Canada Regulations
AstraZeneca An Employer of Choice: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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package! If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today!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 #39;s why we work, on average, a minimum of three days per week from the office. But that doesn #39;t mean we #39;re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Date Posted08-Nov-2023Closing Date06-Dec-2023AstraZeneca 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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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