- A Bachelor's in sciences/pharmacy/nursing degree or related field
- 3+ years of proven 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
- MSc/PhD/PharmD in scientific field
- 2+ years of relevant experience
- Understanding of epidemiology
-
Associate Director, Patient Safety Scientist
19 hours ago
AstraZeneca Gaithersburg, United StatesAssociate Director, Patient Safety Scientist · Location: Onsite 3 days in Gaithersburg · This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scient ...
-
AstraZeneca PLC Gaithersburg, United StatesAre you a motivated cell biologist with experience of in vitro work in molecular biology, immunological based assays? Do you also enjoy working hands-on in the lab with a great group of colleagues by your side? If yes, this might be the next position for you We are looking for a ...
-
Associate Director, Patient Safety Scientist
1 week ago
AstraZeneca PLC Gaithersburg, United StatesAssociate Director, Patient Safety Scientist · Location: Onsite 3 days in Gaithersburg · This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scient ...
-
Director, Principal Patient Safety Scientist
1 week ago
AstraZeneca PLC Gaithersburg, United StatesJob Title: Director Principal Patient Safety Scientist · Location: Gaithersburg MD · At AstraZeneca, we deliver life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Crafting a more agile and inclusive environment means building ...
-
Director, Principal Patient Safety Scientist
1 week ago
AstraZeneca PLC Gaithersburg, United StatesLocation: Gaithersburg (3 days on site) · Do you have expertise in, and passion for Pharmacovigilance? Would you like to apply your expertise to lead on complex PV projects in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might ...
-
AstraZeneca PLC Gaithersburg, United StatesJob Title: Associate Director Senior Patient Safety Scientist · Location: Onsite 3 days in 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 ...
-
AstraZeneca PLC Gaithersburg, United StatesJob Title: Associate Director Senior Patient Safety Scientist · Location: Onsite 3 days in 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 ...
-
AstraZeneca, plc Gaithersburg, United StatesAssociate Director Senior Patient Safety Scientist. Location: Onsite 3 days in 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. Director, Scientist, Patient, ...
-
Scientist, Oncology Ttd Target Discovery
1 week ago
AstraZeneca Gaithersburg, United States**Scientist, Oncology TTD Target Discovery** · **Gaithersburg, MD** · Are you a motivated independent lab Scientist with wet-bench laboratory experience? Do you have a passion for advancing the field of Oncology? If so, we have an exciting opportunity for you to join our Tumor Ta ...
-
Assoicate Principal Assay Scientist
2 days ago
AstraZeneca Gaithersburg, United States**Associate Principal Assay Scientist** · Join us at AstraZeneca, where we turn ideas into life-changing medicines. We are looking for a Associate Prinicpal Assay Scientist to join our Biologics Engineering (BE) team based in Gaithersburg, Maryland US. The Assay hub at Gaithersbu ...
-
Associate Quality Assurance Specialist
1 week ago
ATCC Gaithersburg, United StatesOverview: · Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking an Associate Quality Assurance Specialist to support quality in the repository for Gaithersburg, MD. · Embark on a career where you'll be instrumental in ...
-
Safety, Health
1 week ago
AECOM Germantown, United States**Company Description** Work with Us. Change the World.** · At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world' ...
-
Lead Clinical Laboratory Scientist
4 days ago
US National Institutes of Health Montgomery County, MD, United States**Duties**: · **As a GS Lead Clinical Laboratory Scientist (Hematology), your duties may include, but are not limited to the following**: · - Performs routine and specialized testing in the following Hematology Service Sections: Automation, Morphology, Coagulation, Bone Marrow Im ...
-
Environmental Scientist
1 day ago
Apex Companies, LLC Rockville, United StatesPosition: Environmental Scientist · Industry: Science Technical · Location: Rockville, MD · Compensation: $50k-$65k · Are you highly motivated, hard-working, and seeking to join a growth-focused environmental consulting & engineering firm? Are you looking for a company that will ...
-
Vp - Product Development
1 week ago
OriGene Technologies Inc Rockville, United States: · - Conduct high-level industry research to develop effective sales solutions · - Work with internal R-D to develop innovative product/services · - Introducing external products for OEM option · - Promote the company's products or services to prospective clients · - Participate ...
-
Associate Scientist 1
1 week ago
MilliporeSigma Rockville, United StatesWork Your Magic with us Start your next chapter and join MilliporeSigma. · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our s ...
-
R Shiny Programmer
1 week ago
The EMMES Corporation Rockville, United StatesOverview: · **R Shiny Programmer** · **US Remote** · Emmes Group: Building a better future for us all. · Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes m ...
-
Associate Vice President, Data Science
1 day ago
The EMMES Corporation Rockville, United StatesOverview: · **Associate Vice President, Data Science & AI** · **US Remote** · Emmes Group: Building a better future for us all. · Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Gro ...
-
Health Sciences Safety Specialist
2 days ago
US National Institutes of Health Bethesda, United States**Duties**: · - Develops, implements, and maintains ongoing programs, projects, and initiatives to promote a safe and healthy work environment for NIH employees, patients, visitors, and guest workers. · - Performs investigations and interviews to follow up on incidents involving ...
-
Scientist
1 day ago
CAMRIS Bethesda, United StatesOverview: · CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems ...
Associate Director, Senior Patient Safety Scientist - Gaithersburg, MD, United States - Workday
Description
Job Title: Associate Director Senior Patient Safety Scientist
Location: Onsite 3 days in 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
Preferred Education, Experience and Skills
AstraZeneca An Employer of Choice:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Date Posted
18-Apr-2024Closing Date
06-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.#J-18808-Ljbffr
