Senior Pharmacovigilance Medical Director

Astra Usa   •  

Gaithersburg, MD

Industry: Biotech/Pharma


Not Specified years

Posted 357 days ago

Main Duties and Responsibilities

As the Senior Pharmacovigilance Medical Director you will be responsible for recruiting and managing a team of safety physicians which contributes to ensuring that an adequate number of qualified physicians and staff is available for Patient Safety to satisfy AstraZeneca’s objectives in the Patient Safety area.  You will be expected to act as delegate for the TA VP of Patient Safety. You will ensure that your own work and work of team is compliant with relevant internal and external regulations and standards.  You will use your expertise and knowledge of global issues to develop strategic Physicians and Scientists objectives for inclusion into business objectives.  You will be responsible for providing Disease Area strategic input to a group of drugs in development and post-marketing programs across life-cycle of these substances and products.  You will be defining strategies or lead AstraZeneca’s response to complex technical issues for specific safety aspects in relation to current drug projects, new drug projects and various improvement plans.  You will represent content matter expertise at high level decision-making bodies.  You must be able to work across a number of disease areas in the TA and oversee delivery.  You must be able to represent Patient Safety in external regulatory meetings.  You will influence our strategy and the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organization.  You will review regulatory communication and preparation of higher level documents.  You will closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans.  You will follow important developments and trends in scientific literature and develops contacts with opinion leaders.

Essential Requirements

  • Degree in medicine and experience as a physician or academic
  • 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 Requirements

  • PhD in scientific discipline
  • Extensive general medical knowledge
  • Able to work across TAs and Functions
  • Research background including peer reviewed publications

Job reference: R-007502