At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.We do this with integrity even in the most difficult situations because we are committed to doing the right thing. Patient Safety at AstraZeneca is now looking for an experienced Senior Patient Safety Scientist to join our Patient Safety BioPharma team in Warsaw Poland. The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market
As a Senior Patient Safety (PS) Scientist, you will work collaboratively with other PS Scientist(s) 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.
In this exciting and challenging role, you will provide leadership in aggregating, reviewing, analyzing and interpreting safety data to generate information to support safety decision-making by prescribers, patients, health authorities and payers, with the ultimate goal of protecting patients. You will apply your strong pharmacovigilance, therapeutic area and scientific experience, knowledge and skills to lead in 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. You evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
Main Responsibilities Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
Leads the collaboration with Global Safety Physician (GSP) and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Leads and/or conducts proactive pharmacovigilance and risk management planning for complex products, including preparation of the safety aspects of Global Risk Management Plans in partnership with the GSP and others as appropriate.
Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
Trains and mentors junior members of the team, e.g. in PV processes, analytic methodologies, etc.
Minimum Education, Experience and Skill Requirements A Bachelor's in sciences/pharmacy/nursing degree or related field
3+ years of relevant experience from pharmaceutical or biotech industry
Patient Safety and/or Clinical/Drug Development with 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 (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)
Safety 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 and recognizing key issues
Ability to work effectively in an advanced matrix structure
Proficient in English language
Preferred Education, Experience and Skills MSc/PhD/PharmD in scientific field
Understanding of epidemiology
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next? Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.
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