Principal/associate Director, Safety Physician (new Modality)

AstraZeneca

Clinical safety strategy
Patient benefit risk assessment
Pharmacovigilance
Be responsible for the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project team/governance level

Job Summary

  • Be responsible for the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project team/governance level.
  • Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
  • Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities for all products in area or responsibility.

Matching Summary

Be responsible for the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project team/governance level.

Skills & Requirements

Must-have

  • Clinical Safety strategy
  • Patient Benefit risk assessment
  • pharmacovigilance
  • medical content of safety specification
  • risk-minimisation strategies

Nice-to-have

  • inclusive and diverse team
  • harnessing industry-leading skills
  • wide range of perspectives

Key Requirements

  • Medical degree
  • At least 5 years of Drug Development/Patient Safety experience
  • Good knowledge of international guidelines ICH/GCP
  • Excellent knowledge of relevant local legislation
  • Drug development experience

Work Rights

Not specified

Tailored Resume

Cover Letter