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Head of Multiprogram Pharmacovigilance Oncology

Plats Gaithersburg, Maryland, USA Jobb-id R-090520 Datum inlagd 09/14/2020

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

Patient Safety at AstraZeneca is now looking for Heads of MultiprogramPharmacovigilance (PV) Oncology to join our teams in Gaithersburg, US. or Cambridge UK

The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market.

What you’ll do

The PV Head is a global role providing strategic PS input for TA and/or Disease Areas and quality and compliance oversight to a family of drug development and post-marketing programs across life-cycle of substances and products. This includes dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, risk management commitments, risk mitigation and communication.

The PV Head recruits and manages a global team of safety physicians and scientists, or recruit and manage a global team of group leaders and scientists and physicians,  in order to support major PS programs and key initiatives.

Your main accountabilities / responsibilities:

In the role as the Head of Multiprogram PV Oncology, you will:

  • Recruit and manage team of safety physicians and scientists supporting major programs, or recruit and manage team of group physician and scientist leaders.
  • Drive staff development in support of AZ products
  • Contribute to ensure that an adequate number of qualified physicians and staff is available for Patient Safety to satisfy AstraZeneca’s objectives in the Patient Safety area
  • Ensure that own work and work of team is compliant with Good  Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
  • Use expertise and knowledge of global issues to develop strategic Physicians and Scientists objectives for inclusion into business objectives
  • Provide TA Disease Area strategic PS input to a family of drug development and post-marketing programs across life-cycle of substances and products – e.g to dTPPs, patient populations, scientific  understanding of toxicity-related mechanisms, ensure risk management commitments, risk mitigation and communication.
  • Be accountable at Portfolio-level for quality incl review of key deliverables (eg RMPs and PSRs),  and adherence to PV regulations.
  • Define strategies or leads 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 relevant PSTAVP
  • Be responsible for SIRC Chair role and Chairperson consultation for assigned products
  • Chair Patient Safety peer review
  • Work across a number of disease areas in the TA and oversee Safety Physicians, Sceintists and SSaMTs working in a portfolio of AZ assets in the TA
  • Represent AZ PS in external regulatory meetings
  • Influence AZ TA strategies
  • Influence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organisation
  • Review regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR)
  • Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans
  • Follow important developments and trends in scientific literature and develops contacts with opinion leaders
  • Share best practice in PS TA
  • Participate in the respective PSTA leadership team

Essential for the role

  • Minimum PhD.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

  • MD and or extensive experience in a scientific discipline
  • Extensive general medical knowledge
  • Able to work across TAs and Functions
  • Research background including peer reviewed publications

So, what’s next?

Apply directly on site as soon as possible. AstraZeneca in hiring and onboarding Virtually during the Covid 9 crisis in the US.

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.

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