Associate Director, Senior Patient Safety Scientist
Are you ready to lead the charge in ensuring patient safety and making a real difference? As an Associate Director, Senior Patient Safety Scientist, you will spearhead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Program Lead, (GSPL). You will author and lead PV input to safety documents and regulatory reports, lead meetings, and present safety data and analyses. Join us in our mission to deliver life-changing medicines to patients worldwide.
Accountabilities
Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSPL and others as appropriate.
Lead PS activities of cross-functional project teams for marketed products and/or developmental compounds.
Provide safety expertise to Investigator Brochures and Protocols, Informed Consents, and Clinical Study Reports.
Present complex issues to the Safety Information Review Committee (SIRC) and take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSPL, and other key partners.
Collaborate with GSPL and Clinical representatives to author the Reference Safety Information (RSI) for multiple or complex marketed products and/or development products.
Author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Participate in negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
Train and mentor junior members of the team in approved PV processes, analytic methodologies, etc.
Author/provide strategic leadership to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSPL and other functional experts.
Essential Skills/Experience
Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development
Comprehensive understanding of applicable Patient Safety regulatory obligations
Awareness of Patient Safety policies, processes, and procedures
Awareness of medico-legal aspects of patient safety
11 to 13 years Patient Safety experience (Pharmacovigilance)
Total of 14 to 16 years of experience
Desirable Skills/Experience
Well-developed interpersonal skills
Cultural sensitivity
Ability to network with other functions globally
Site Description:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of BioPharmaceuticals and Oncology R&D in the US. Here, we play host to some of the most innovative technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly designed, activity based work spaces to suit a variety of working styles while increasing collaboration between teams.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a biopharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Diversity and Inclusion at AstraZeneca
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive team that represents a diverse group of backgrounds and perspectives, knowing that inclusion drives better outcomes.We welcome all qualified candidates and align with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations during the application or interview process, as well as for essential job functions.
The annual base pay (or hourly rate of compensation) for this position ranges from $110,754 to $166,130. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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