AstraZeneca · 4 hours ago
Director, Principal Patient Safety Scientist
US - Gaithersburg - MD
Full-time
Hybrid
Lead/Staff, Director/Executive
8+ years expAstraZeneca is a global biopharmaceutical company that prioritizes patient needs and aims to meet unmet medical requirements worldwide. The Director, Principal Patient Safety Scientist role involves providing expertise in pharmacovigilance and risk management for complex products, overseeing safety documents, and leading safety strategies in collaboration with cross-functional teams.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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 and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate
Provides subject matter expertise in the therapeutic area and across multiple products
Has the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization
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)
Leads safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) 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
Leads negotiations and provides expertise to the PS 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 PV Scientists in approved processes and systems
Qualification
Required
Minimum 8 years of experience
Minimum Life sciences/Pharmacy/Nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development experience
Advanced knowledge of PV regulations
Preferred
MD/MSc/PhD in scientific field
Advanced understanding of epidemiology
Benefits
Health, dental, and vision coverage
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Short-term incentive bonuses
Equity-based awards for salaried roles
Commissions for sales roles
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
Company data provided by crunchbase