Associate Director, Senior 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 Associate Director, Senior Patient Safety Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. They author and leads PV input to safety documents and regulatory reports. Associate Director, Senior Patient Safety Scientist leads meetings and presents safety data and analyses.

Requirements

• Minimum 5 years of experience
• MSc Degree preferred
• A Life sciences/Pharmacy/Nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Advanced knowledge of PV regulations

Nice To Haves

• MD/PhD in scientific discipline, desireable
• Intermediate understanding of epidemiology, preferred

Responsibilities

• Leads and/or conducts proactive pharmacovigilance and risk management planning for more sophisticated 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.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
• Presents sophisticated issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key partners.
• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
• Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

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.

What This Job Offers

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