Director, Principal Patient Safety Scientist

AstraZeneca • Gaithersburg, MD

1d • Hybrid

About The Position

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The Director, Principal Patient Safety Scientist role provides expertise to multiple and/or single but sophisticated products in different stages of development as needed. They provide oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. They lead PV strategy for safety documents and regulatory reports.

Requirements

• 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

Nice To Haves

• MD/MSc/PhD in scientific field, preferred
• Advanced understanding of epidemiology, preferred

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.

Benefits

• Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
• AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
• AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [e-mail].

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level