.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 vaccines & medicines and the safety science of the programs.
AstraZeneca's pipeline includes novel combinations and modalities, providing an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects.
We are looking for an Associate Director, Patient Safety (PS) Scientist to join our Global Patient Safety V&I team, working in the Vaccines & Immune Therapies 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 support the safety strategy and requirements for your assigned 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.
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 transformative development programs ever.
Essential 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.
Patient Safety and/or Clinical/Drug Development demonstrable 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