Director, Principal Patient Safety Scientist
Location: Waltham MA
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 Biopharma at AstraZeneca is now looking for a Director, Principal Patient Safety Scientist
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.
What you'll do
The Principal Patient Safety Scientist is a global role providing expertise to multiple and/or single but complex products in different stages of development within the therapy areas of Respiratory & Immunology and Cardiovascular, Renal & Metabolism. The role holder provides oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other Patient Safety Scientists.
In this exciting and challenging role, you will work collaboratively with other Patient Safety Scientists and physicians to shape the culture of the safety team and the wider PSTA function. You will facilitate collaboration with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
Your main accountabilities / responsibilities:
Leads the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans in partnership with the Global Safety Physician (GSP) and others as appropriate.
- Leads safety strategy for multiple or complex periodic regulatory documents according to the agreed process and timelines.
- Leads safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
- Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.
- As a Safety expert leads presentation of complex issues to Safety Information Review Committee (SIRC).
- Has the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.
- Leads negotiations and provides expertise to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreements.
- Takes accountability and leads resolution of complex safety issues and mediates cross-functional agreement.
- Has the ability to participate in due diligence activities.
- As a safety expert provides training and mentorship to new GSPs and Patient Safety Scientists in processes and systems.
Essential for the role
- BSc in sciences/pharmacy/nursing or related field
- 7+ years of relevant experience
- Advanced Patient Safety and/or Clinical/Drug Development experience of leading safety &/or scientific activities, across at least 4 of the following areas:
- Clinical drug development (Early and/or Late Phase: develop program level safety strategy, including proactive risk identification & mitigation planning)
- Post-Marketing Surveillance (including signal detection & evaluation)
- MAA/BLA submissions (setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document)
- Periodic Safety Reports (establish and lead strategy, preparation and authoring)
- Risk Management Plans (establish and lead strategy, preparation and authoring)
- Governance board interactions and communication across a range of activities
- Advanced knowledge of PV regulations
- Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues
- Ability to work effectively in an advanced matrix structure
- Proficient in written and verbal English
Desirable Qualifications for the role
- MSc or PhD in relevant scientific field preferred
- Strong network and reputation within the business and industry
- Extensive knowledge of the latest technical and regulatory expectations
Date Posted
14-Aug-2024Closing Date
29-Sep-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.