Global Safety Program Lead

Job Title: Global Program Safety Lead
Location: Gaithersburg

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.

Introduction to Role:

The individual is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the role holder will work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and / or scientists. They will be required at times to deputise for the Global Safety Head.

The individual will operate according to the highest ethical, quality and compliance standards in compliance as provided by global and local regulations, GxP practice and AZ procedures.

Accountabilities:

Safety Expert

• Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.

• Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).

• Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy.

• For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset

• Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.

• Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).

• Leads response to complex technical issues for specific safety aspects for the assigned asset(s).

• Is accountable for safety contribution to study designs and study concept delivery within their assigned program

• Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).

• Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset.

• Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.

• Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team.

• May be required to support in-licensing opportunities.
• Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours

• Accountable for implementation of new processes, systems and learning, including new ways of working.

• Prioritizes risk mitigation strategies and effective trouble shooting.

• Line manages a team of safety physicians and / or scientists.

Scientific clinical safety analytical accountabilities

• Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information,

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