Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca drug projects and products throughout all stages of development and/or when on the market
Job Summary
Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca drug projects and products throughout all stages of development and/or when on the market.
Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, dRMP, CPRL and globally reviewed LRMPs.
Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.
Matching Summary
Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca drug projects and products throughout all stages of development and/or when on the market.
Skills & Requirements
Must-have
Clinical Safety strategy
Risk assessment and mitigation
Pharmacovigilance plan
Regulatory safety queries
Benefit/risk assessment
Nice-to-have
Cross-functional collaboration
Team player
Challenging the norm
Diversity and inclusion
Key Requirements
Medical degree (MD, MBBS)
2 years clinical experience post-registration
2 years Drug Development/Patient Safety experience