Associate Director, Senior Patient Safety Scientist

AstraZeneca • Gaithersburg, MD

135d

About The Position

At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we do the right thing. This opportunity enables you to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists play a strategic role in developing our medicines and the safety science of the program. AstraZeneca's oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects. Our combined experience develops as our portfolio does. We are looking for an Associate Director, Senior Patient Safety (PS) Scientist to join our Patient Safety department, working in the Oncology Therapeutic Area. In this exciting role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians. You will play a role supporting the safety strategy and requirements for your assigned drug project(s). Your collaboration skills will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. As an Associate Director, Senior PS Scientist, you will be involved in aggregating, reviewing, analyzing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. You will apply your PV, oncology and scientific experience, knowledge and skills to deliver all aspects of safety documentation, including authoring and / or providing strategic safety input to regulatory documents, e.g., regulatory reports, health authority responses and the safety content of marketing authorization applications. If this sounds appealing to you, why wait? Apply now! Patient Safety sits within the Chief Medical Office, where we play a crucial role. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Faced with complex disease challenges, we focus on outstanding performance to drive the best and most progressive drug development programs ever.

Requirements

• A Bachelor's in sciences/pharmacy/nursing degree or related field with a minimum of 3 years of experience or an advanced degree with 2 plus years of relevant experience.
• Proven experience in Patient Safety and/or Clinical/Drug Development 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.
• 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.
• Fluent in written and verbal English.

Nice To Haves

• MSc/PhD/PharmD in scientific discipline.
• Understanding of epidemiology.

Responsibilities

• Work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians.
• Support the safety strategy and requirements for assigned drug project(s).
• Facilitate cross-functional interactions with colleagues from Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
• Aggregate, review, analyze and interpret safety-related data to support safety decision-making.
• Deliver all aspects of safety documentation, including authoring and providing strategic safety input to regulatory documents.

Benefits

• 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: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree