Associate Director Senior Patient Safety Scientist

AstraZeneca • Gaithersburg, MD

1d • Onsite

About The Position

At AstraZeneca, we are dedicated to delivering innovative medicines to patients globally, making an impact and finding solutions to challenges with integrity. This role offers an opportunity to advance pharmacovigilance (PV) experience within safety programs, covering the entire drug development lifecycle and peri-/post-submission phases. Scientists and Physicians at AstraZeneca play a strategic role in medicine development and program safety science. The oncology pipeline, featuring novel combinations and modalities, presents an intellectual challenge for safety teams, demanding a broad portfolio and scientific management approach. We are seeking an Associate Director, Senior Patient Safety (PS) Scientist to join the Patient Safety department within the Oncology Therapeutic Area. In this challenging role, you will collaborate with the Global Safety Physician (GSP) and other PV Scientists and physicians, supporting the safety strategy and requirements for assigned drug projects. Your collaborative skills will facilitate cross-functional interactions with colleagues from Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. As an Associate Director, Senior Patient Safety Scientist, you will be responsible for aggregating, reviewing, analyzing, and interpreting safety-related data to generate information that supports safety decision-making for prescribers, patients, and payers, ultimately aiming to protect patients. You will apply your PV, oncology, and scientific expertise to deliver all aspects of safety documentation, including authoring and/or providing strategic safety input to regulatory documents such as regulatory reports, health authority responses, and the safety content of marketing authorization applications. Patient Safety is a crucial part of the Chief Medical Office, and this is an exciting time for the team, with a drug-development pipeline offering incredible opportunities to push scientific boundaries and deliver life-changing medicines. The focus is on exceptional performance to drive the best and most progressive drug development programs.

Requirements

• A Bachelor’s in sciences/pharmacy/nursing degree or related field
• Minimum of 3+ years of validated 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 (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning), Post-Marketing Surveillance (including signal detection & 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

Nice To Haves

• MSc/PhD/PharmD in scientific field
• 2+ years of relevant experience
• Understanding of epidemiology

Responsibilities

• Work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians
• Play a role supporting the safety strategy and requirements for your 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, with the ultimate goal of protecting patients
• 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

Benefits

• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles
• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Competitive Total Reward program including a market driven base salary, bonus and long term incentive
• Generous paid time off program
• Comprehensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees