Director, Global Patient Safety Physician, US

Director, Global Patient Safety Physician, US

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

At AZ, we’re proud to have an exceptional workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives – and made to feel valued, energized and rewarded for their ideas and creativity. AZ is a place where passionate people can immerse themselves in their work and make significant contributions to scientific excellence and medicines – does this describe a place where you would like to work?

Role Profile:

• Ability to provide overall direction, developing and managing a team or projects within the PS function by setting clear guidance to ensure implementation of all PS Science activities as per local health authorities regulations and AstraZeneca requirements.

• Leading the daily PS operation activities and ensure the team is structured, staffed, trained, motivated, and resourced properly to run all patient safety duties in compliance with local regulations and good pharmacovigilance practice.

•  Manage high-level risk by making complex judgments and developing innovative solutions.

• Expert in the Patient safety field and possesses an in-depth knowledge of the local health authority regulations and global PS requirements.

• Maintain oversight of all patient safety-related processes, activities, issues, and gaps at the country/regional level and lead the necessary actions.

• Showing strong collaborative communication skills, including the ability to engage cross-functional teams and influence a diverse range of internal & external stakeholders. 

• Operate according to the highest ethical standards in compliance with global PS SOPs, and local regulations.

• Ability to implement patient safety strategy and provide regular input to improve the current processes and influence the team to excel in their roles and to maximize the outcomes and deliverables. 

Accountabilities & Responsibilities:

• The Director, GPS Physician is a medical specialist accountable for medical appropriateness with local regulatory requirements and deliverables for pharmacovigilance activities, in accordance with post-marketing AZ product strategy.

• Lead safety medical science to ensure the medical quality of safety measures at the local country level.

• Develop and improve the medical knowledge of the local Patient Safety Science team by giving adequate opportunities for medical training.

• Promote local PS strategies & provide the necessary support for its implementation.

• The Director, PS Physician promotes the safety of patients who receive AstraZeneca products, to optimize overall benefit/risk with a focus on assigned TA(s) in the local market.

• The role holder is accountable for patient safety Science activities, and for providing medical leadership as a safety expert for assigned products in assigned therapeutic area(s) (TA).

• Providing guidance and mentorship to Patient Safety Science scientists and junior or new safety physicians and ensure effective collaboration with stakeholders in cross-functional teams.

•  The role holder is accountable for post-marketing science activities and for providing safety input and support to medical and brand team activities, including the development of safety strategy, support product launch planning, safety support to locally sponsored clinical and real-world evidence (RWE) studies, safety review of externally sponsored research (ESR), contribution to regulatory submissions and product labeling activities, and accountable for PS specific documents such as periodic safety reports (i.e., PADERs) or regulatory responses as appropriate.

•  The role holder may also contribute to Global benefit-risk assessment, risk management strategies, and related activities.

• The role holder ensures that all work is carried out with regards to AstraZeneca standards and external regulations, and closely collaborates with other relevant stakeholders in the global and local business (including regulatory, Medical Affairs, Real World Evidence, and legal)

• Ensures efficient and effective leadership and management of project information, strategy, quality standards, and integrity of information interpretation. If required, the role holder may collaborate with Global Patient Safety on Glob