Associate Director Senior Patient Safety Scientist
Required skills
MD, MSc, PhD, or PharmD in a scientific field; Minimum of 6+ years of relevant experience; Patient Safety and/or Clinical/Drug Development proven experience working in safety and/or scientific activities in at least 3 of the following areas: Clinical drug development (Early and/or Late Phase: develop and deliver program level safety strategy, including proactive risk identification and mitigation planning), Post-Marketing Surveillance (including signal detection and evaluation), MAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document), Periodic Safety Reports (deliver strategy, preparation and authoring), Risk Management Plans (deliver strategy, preparation and authoring); 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 skills
Strong knowledge of hematology; Understanding of epidemiology.
Responsibilities
Further develop pharmacovigilance (PV) experience in safety programs spanning the entire life cycle of drug development and peri-/post-submission; Play a strategic role in developing medicines and the safety science of the program; Support the safety strategy and requirements for assigned drug project(s); Facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams; Aggregate, review, analyze, and interpret safety-related data to generate information to support safety decision-making by prescribers, patients, and payers; Apply PV, oncology, and scientific experience, knowledge, and skills to deliver all aspects of safety documentation; Author and/or provide strategic safety input to regulatory documents, e.g., regulatory reports, health authority responses, and the safety content of marketing authorization applications.
Seniority
Associate Director.
Domain
Oncology Therapeutic Area; Pharmacovigilance; Patient Safety.
