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Associate Director Risk Management, additional Risk Minimization Measure (aRMM)

Location Cambridge, England, United Kingdom Gaithersburg, Maryland, United States Barcelona, Catalonia, Spain Waltham, Massachusetts, United States Gothenburg, Västra Götaland County, Sweden Job ID R-129698 Date posted 04/07/2022

Assoc. Dir, Risk Management, additional Risk Minimization Measures (aRMM)

The role holder has knowledge of pharmacovigilance processes, including Risk Management (RM). The role holder works closely with other Risk Management Group members within the Patient Safety Centre of Excellence (PS CoE), Patient Safety Scientists and Marketing Company (MC) safety personnel.  The role holder is responsible for the effective, efficient and compliant implementation, execution and oversight of risk management plan requirements including additional risk minimization measures globally including:

  • Ensuring compliance with applicable regulations and AstraZeneca Global Policies.
  • Collaboration with functions in R&D, Commercial, Marketing Companies (MC), Regulatory Affairs, Medical Affairs and AZ Legal.
  • Collaboration with other members of the PS CoE to share best practice, ensure consistency and compliance

Responsibility

  • Provide local support and monitor all activities and plans associated with AZ products’ Risk Management Plans (RMPs) and post-marketing commitments globally including:
    • Contribute to the development of new/revised Core/EU additional RMM and country specific additional RMM
    • Manage/oversee timely implementation of the additional RM activities globally to meet regulatory commitments and internal standards.
    • Conduct Risk Management system/process hypercare sessions with MCs
    • Provide data and/or expert input into Health Authority Questions
    • Collaborate with internal stakeholders from medical, regulatory, patient safety and commercial, as required to ensure updated aRMMs are available
    • Provide RMP activity implementation training as required to internal stakeholders
  • Work with the RMP tracking system business tool owner/system owner, supports the operational oversight and development of the RM Tracking tool including:
    • Contribute to procedural documents and end-user training
    • Ensure that relevant Key Performance Indicators (KPIs) and other metrics are reported from the risk management tracking tool to support oversight.
    • Serve as back up for operational liaison with Feith Systems and Software, Inc. (risk management tracking tool vendor) to resolve any system operations issues.
    • Identify  process and/or systems improvements to increase quality and/or efficiency
    • Support implementation of risk management tracking tool upgrades and system enhancements.=
    • Perform regular quality checks of the RM tracking tool and data stored therein
  • Contribute to development of risk management procedural documents such as SOPs and Working Practice Documents in the capacity of a subject matter expert.
  • Participate in and/or support activities for GVP, GCP, GRP and GMP audits/inspections related to RM as required and deliver Corrective and Preventative Actions to time and quality and identify data or trends identified through the Quality and Management Process.
  • This position reports to the Head, Risk Management Group.
  • Oversee vendor activities and commitments related to RM activities as required
  • Identify opportunities and drive the development and/or enhancement of standards, techniques and technology in collaboration with internal/external stakeholders to improve the quality and efficiency of RM activities
  • Actively contribute to the development of short term objectives and the long term vision of the RM group and identify any risk and issues within the RM processes/systems and propose solutions to mitigate them.

Required

  • A Bachelor’s degree with at least 5 years’ relevant experience (pharmaceutical, regulatory, safety and partnership) and 3 years’ experience in patient safety/pharmacovigilance
  • Knowledge and understanding of relevant global regulatory requirements and an ability to interpret these standards to achieve business goals
  • Experience in design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes
  • Experience of development and provision of training through virtual meetings and other media
  • General knowledge of project management skills, experience in audits/inspection activities related to PV
  • Able to work with  a degree of autonomy able to represent AstraZeneca externally where required
  • Ability to rapidly comprehend the AZ organization and agility in maneuvering across the organization
  • Good strategic thinking capability,  excellent communication and time management skills
  • Highly motivated self-starter who is able to prioritize competing work assignment demands with minimal supervision

Desired

  • Knowledge of new and developing regulatory and pharmacovigilance expectations
  • A science/pharmacy/nursing degree
  • Experience of authoring standards documents (Standard Operating Procedures)
  • Experience working with external vendors, excellent project management skills
  • Experience of working in a global organization, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
  • Experience preparing and/or implementing risk management plans and/or risk minimization measures globally
  • Knowledge/experience of communicating health messages via digital media (e.g. websites, apps etc.).

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 authorization 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.

50056684 E PRBI R&D Oncology

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