Head of Pharmacovigilance Hematology

Gaithersburg, Maryland, USA
16 Apr 2021
21 Apr 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases.

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us.

What you'll do

Our Patient Safety Oncology team has a unique opportunity for a Head of Pharmacovigilance Hematology to join the Leadership Team. This is a global role providing strategic Patient Safety input along with quality and compliance oversight to a family of drug development and post-marketing programs. This includes dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, risk management commitments, risk mitigation and communication.

You will recruit and manage a global team of group leaders, safety scientists and physicians in order to support major Patient Safety programs and key initiatives within Oncology R&D. Part of your line management responsibility will include driving employee development in support of AstraZeneca products, ensuring that adequate resource is available for Patient Safety to satisfy our objectives in Patient Safety

Your main accountabilities will include, but are not limited to:

  • Monitor compliance with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
  • Be accountable at Portfolio-level for quality including review of key deliverables (eg RMPs and PSRs) and adherence to pharmacovigilance regulations.
  • Define strategies and lead AstraZeneca's response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans
  • Represent content matter expertise at high level decision-making bodies such as LSPC, SARB, ESBand Development Review Committee on behalf of the Patient Safety Oncology Vice President.
  • Influence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs Leaders in Oncology and with the Commercial organisation
  • Closely follow medical developments and disseminate new information within Patient Safety to transform trends and emerging data into new plans

Essential for the role

  • MD, MBBS or PhD and Medical/clinical/scientific qualification and postgraduate training, or equivalent standards
  • Experience in providing strategic leadership to complex drug projects
  • Relevant industry experience in Pharmacovigilance field
  • Experience in managing a scientific team
  • Demonstrated ability to influence key stakeholders within and outside of company
  • Demonstrated proficiency with both written and verbal communications

Desirable for the role

  • Extensive general medical knowledge
  • Able to work cross-functionally
  • Research background including peer reviewed publications

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

Are you ready to bring new ideas and fresh thinking to the table? Apply today for quick consideration.

Where can I find out more?

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