Associate Director Senior Patient Safety Scientist Full-time

Associate Director Senior Patient Safety Scientist

Location: Gaithersburg, MD

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 are committed to doing the right thing.

This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians 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 teams' 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 and challenging 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 ability to work collaboratively 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 Patient Safety 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.

Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. 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 exceptional performance to drive the best and most progressive drug development programs ever!

Minimum Education, Experience and Skill 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

Preferred Education, Experience and Skills

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