Skip to main content
Search roles

Sr. Director Risk Management, Patient Safety CoE

Location Gaithersburg, Maryland, United States Warsaw, Mazovia, Poland Cambridge, England, United Kingdom Gothenburg, Västra Götaland County, Sweden Job ID R-129514 Date posted 31/01/2022

The Sr. Director Risk Management, Patient Safety CoE role holder has specialist knowledge in Risk Management and a broad based knowledge in patient safety. Provides leadership and strategic direction to the development of state-of-the art risk management methods, tools and technology. Provides expertise, training & oversight in RMP strategy, content standardization, quality & implementation across TAs and Marketing Companies(MCs).  Leads development of global risk management plan related regulatory strategies in collaboration with PSTAs, clinical, medical affairs and regulatory affairs.  Leads development and oversees implementation of additional risk minimization strategies & assessment of effectiveness in collaboration & consultation with key stakeholders (PSTAs, MCs, GMA) & external vendors. Leads development of novel technology and methodology in the area of risk management and risk minimization. Contributes to scientific advancement of the field of risk management through scientific publications and presentations and external consortia. They are recognised as an expert in own field internally and externally and work on complex strategic problems and provide solutions that are highly innovative.  They possess strong external collaborations/networks enabling them to influence RMP regulation & scientific development.

Specific Accountabilities:

  • Leads development of global risk management plan related regulatory strategies in collaboration with PSTAs, clinical, medical affairs and regulatory affairs. 
  • Develops and maintains a framework for training and oversight in RMP strategy, content standardization, quality & implementation across TAs and Marketing Companies(MCs). 
  • Leads development of additional PV, risk minimization strategies & assessment of effectiveness in collaboration & consultation with key stakeholders (PSTAs, MCs, GMA) & external vendors
  • Oversees design, implementation and maintenance of additional risk minimization measures and materials
  • Oversees review and endorsement of all LRMPs and associated activities to ensures a consistent approach to LRMP content and compliance with Health authority requirements
  • Performs quality review of Core & EU RMPs and ensures consistent approach to RMP content across AZ and adherence to Health authority regulatory requirements
  • Provides input into RMP-related Health Authority negotiations
  • Leads development of methods and tools to maintain oversight of global legislative changes and to inform RM strategy and objectives.
  • Provides input into draft regulatory guidance and ensures that the organization is appropriately prepared for new RM related legislation
  • Lead strategy in collaboration with key stakeholders to coordinate capability building related to Risk Management planning within AZ
  • Provides strategic leadership for the design and implementation of RM tools, technology and methodology globally and locally (e.g., RMP portion of sharepoint site, RMP tracker) to support RMP Plan tracking & compliance
  • Leads development of state-of-the art risk management/risk communication methods, tools and technology.
  • Oversees the development and implementation of methods to facilitate to shared learning across PSTAs and MCs in order to promote ‘right first time’ filing strategies for RMPs and associated activities
  • To maintain AZ PS’s differentiating scientific advantage, delivers significant contribution to scientific and technological innovation in the area of risk minimization (external publications, presentations and consortia)
  • Actively contributes to risk management plan audit plans and actively participates in risk management plan related audits and inspections as required

Required:

  • Health professional degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in, life sciences, or related field
  • Extensive experience in patient safety/pharmacovigilance and risk management, including applicable industry experience and seen internally and externally as a subject matter expert
  • Ability to rapidly comprehend the AZ organization and agility in maneuvering across the organization
  • Ability to lead, develop and implement RM strategy regarding patient risk management across geographies and multiple functions including commercial, medical affairs and patient safety
  • Excellent strategic thinking capability, superb communication skills
  • Strong understanding of local Medical Affairs function and ability to translate needs across GMA, Clinical development and MCs
  • Knowledge and comprehension of relevant legislation and translation into best practice
  • Proven ability to communicate and negotiate with major global health authorities

Desired:

  • Regulatory strategy knowledge and experience
  • Strategic knowledge of global healthcare systems
  • Proven ability to lead teams and projects across wide variety of stakeholders
  • Proven ability to develop state-of-the art risk management/risk communication methods, tools and technology.  RMP-related Publications, presentations and representation/leadership in relevant external professional bodies/consortium

US based Employees: AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants.  COVID-19 vaccination is required for all US employees. Individuals who are unable to receive a COVID-19 vaccine based on applicable law, such as medical and religious reasons, can submit a request for a reasonable accommodation.  For employees who are not vaccinated and who are granted an exemption to the vaccine requirement for qualifying reasons, the primary accommodation will remain weekly COVID-19 PCR testing.   



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 authorisation and employment eligibility verification requirements.

10001069 G SCPT R&D Oncology (Susan Galbraith (07016555)) (85008610)

We’ll keep you up to date

Sign up to be the first to receive job updates.

Interested InSearch for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.