Director, Global Patient Safety Physician, US

AstraZeneca•Wilmington, DE

2d•Hybrid

About The Position

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.

Requirements

MD or equivalent degree from US or reputable foreign medical university
2 years of US clinical experience post-registration/certification
5 years or more years experience in drug development and/or pharmacovigilance obtained while working in the pharmaceutical industry and/or academia
High level of medical competence, with an ability to balance this with AZ standards to achieve business goals
Excellent communication skills
High level of medical competence, with an ability to balance this with AZ standards to achieve business goals.
Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions.
Communication skills – knows when and how to communicate, using strong interpersonal skills and written communication when appropriate.
Business English language.
Results Focused – ability to overcome obstacles and achieve key outcomes.
Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas.
Builds effective partnerships – identifies opportunities and takes actions to build effective relationships within the team and with other areas.
Ethics – overriding commitment to integrity and high standards in self and others.
People Management, maximize the staff performance by proper job assignment.
Budget Control.

Nice To Haves

Extensive safety experience in the pharmaceutical industry
Clinical experience post-registration/certification
Experience in drug development and/or pharmacovigilance obtained while working in the pharmaceutical industry.
Experience working in Medical Affairs roles in the pharmaceutical industry.
Extensive working knowledge of epidemiology
Cultural Awareness – able to work successfully in a multicultural environment.
Analytical Thinking - Logically breaking situations or issues down into their essential elements carrying out diagnosis and developing solutions

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 Global projects.
Accountable for GPS activities for PoLO products.
As appropriate, organize the medical training program to raise US PS Science staff’s medical knowledge.
Lead safety Science team and other PS functional teams as appropriate for products in assigned TA(s) to ensure delivery of PS science activities to optimize patients’ benefit-risk profile and to ensure AZ’s license to operate.
Responsible for timely escalation of newly identified safety issues to appropriate stakeholders.
As appropriate, collaborate with GPS and other functional teams to address identified safety issues.
Responsible for strategic safety support to medical and brand teams, including the development of patient-centric safety strategy for high-priority products and safety contribution to patient support programs and medical affairs activities, generation of safety-related medical evidence in addressing products’ evidence gaps (as defined by Medical Affairs) and safety concerns of patients and health care professionals in the marketplace.
Contributes to product benefit/risk assessment, risk management, risk mitigation, and risk communications, as appropriate.
Provide safety leadership and input to and oversight of REMS implementation in collaboration with Global PS, local REMS team, and external vendor (if applicable).
Provides safety and scientific contributions to Medical clinical research activities, including Medical and/or sponsored clinical studies and RWE studies, and contributes safety input to study design concepts as appropriate.
Leads safety review of externally sponsored research (ESR), including IISR and ESCR, in local (or Global as needed) review process and supports ESR management team or medical team in safety issue management as appropriate.
Responsible for strategy, content, and development of local-specific periodic safety reports and supports regulatory affairs in obtaining local health authority waiver as appropriate.
Lead the US PS cross-functional product launch team to establish and implement a safety launch plan to ensure the PS system and organization’s readiness for new product or new indication launches.
Ensure implementation of Global safety strategy and decisions in the local market
Responsible for safety deliverables delegated from Global Patient Safety, including any key safety projects in assigned TA(s).
As requested, provides Patient Safety expertise and contributions to the development of local regulatory response documents.
Contributes Patient Safety expertise and input into local Safety Issue management and Health Hazard Evaluation as appropriate.
Provides PS input as appropriate to product global safety governance teams (i.e., SSaMTs, Pre-SIRC, SIRC) and bridges local market with Global PS in decision-making processes.
Accountable for the development and maintenance of the local Labelled Lists for the global safety database.
Collaborates with external or internal colleagues and experts, provides consultancy in own area of expertise, and serves as a resource for others by sharing experience within and beyond project team and function.
Closely collaborates with other relevant internal stakeholders in the global and local business functions (including regulatory, medical affairs, Real World Evidence, and legal).
Provides litigation safety support upon request.
Mentor junior-level safety physician(s) in safety science activities.