AstraZeneca
Pharma
Director,PrincipalPatientSafetyScientist
“Director, Principal Patient Safety Scientist at AstraZeneca. Skills: Patient Safety, Pharmacovigilance, Risk Management. Lead strategy for proactive pharmacovigilance. Lead risk management planning”
Industry & Context.
Complex safety issues
What They're Looking For.
Must Have
Life sciences/pharmacy/nursing degree, Advanced Patient Safety experience, Advanced Clinical Drug Development experience, Fluent in English, Advanced knowledge of PV regulations
Nice to Have
MD/MSc/PhD in scientific discipline, Advanced understanding of epidemiology
What You'll Do.
Lead strategy for proactive pharmacovigilance
Lead risk management planning
Prepare safety aspects of Global Risk Management Plans
Prepare Risk Evaluation and Mitigation Strategies (REMS)
Provide subject matter expertise
Lead cross-functional process improvement initiatives
Perform duties as Safety Strategy and Management Team
Lead presentation of complex issues
Lead safety strategy for periodic regulatory documents
Lead safety strategy for regulatory submissions
Lead negotiations for contracts/agreements
Provide expertise to PS component of contracts
Lead resolution of complex safety issues
Mediate cross-functional agreement
Participate in due diligence activities
Provide training to GSPs
Provide mentorship to PV Scientists
How You'll Work.
Team & Collaboration
Cross-functional process improvement; Safety Information Review Committee; Global Safety Physician partnership
Communication Scope
Executive presentations
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