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Company

Original Job Post

AstraZeneca · 2 days ago

Associate Director, Senior Patient Safety Scientist - Oncology R&D

Gaithersburg, MD

Full-time

Onsite

Senior Level, Director

3+ years exp

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Comp. & Benefits

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Responsibilities

Aggregating, reviewing, analyzing, and interpreting safety-related data to support safety decision-making.

Collaborating with Global Safety Physician and other PV Scientists to support safety strategy and requirements for assigned drug projects.

Providing strategic safety input to regulatory documents such as regulatory reports and health authority responses.

Handling governance board interactions and communication across various safety and scientific activities.

Working effectively in an advanced matrix structure and prioritizing multiple activities simultaneously.

Qualification

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Clinical Drug DevelopmentPost-Marketing SurveillanceMAA/BLA SubmissionsPeriodic Safety ReportsRisk Management PlansGovernancePV RegulationsMatrix StructureEnglish ProficiencyProblem-SolvingCommunicationTime ManagementEpidemiology

Required

A Bachelor’s in sciences/pharmacy/nursing degree or related field

3+ years of proven experience

Patient Safety and/or Clinical/Drug Development proven experience working in safety &/or scientific activities in at least 3 of the following areas: Clinical drug development, Post-Marketing Surveillance, MAA/BLA submissions, Periodic Safety Reports, Risk Management Plans

Governance board interactions and communication across a range of activities

Good knowledge of PV regulations

Demonstrated ability to handle more than one activity simultaneously, prioritizing well and recognizing key issues

Ability to work effectively in an advanced matrix structure

Proficient in written and verbal English

Preferred

MSc/PhD/PharmD in scientific field

2+ years of relevant experience

Understanding of epidemiology

Benefits

Paid time off

Comprehensive benefits package

Company

AstraZeneca

Glassdoor

4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor AB.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10,001+ employees