AstraZeneca
Executive Director, Multiprogram Patient Safety Oncology
AstraZeneca, Gaithersburg, Maryland, us, 20883
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
Patient Safety at AstraZeneca is now looking for
Heads of Multiprogram Pharmacovigilance (PV) Oncology
to join our teams.
The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market.
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 offices are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
What you’ll do
The PV Head is a global role providing strategic PS input for TA and/or Disease Areas and quality and compliance oversight to a family of drug development and post-marketing programs across life-cycle of substances and products. This includes dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, risk management commitments, risk mitigation and communication.
The PV Head recruits and manages a global team of safety physicians and scientists, or recruit and manage a global team of group leaders and scientists and physicians, in order to support major PS programs and key initiatives.
Your main accountabilities / responsibilities:
Recruit and manage team of safety physicians and scientists supporting major programs, or recruit and manage team of group physician and scientist leaders.
Drive staff development in support of AstraZeneca products.
Contribute to ensure that an adequate number of qualified physicians and staff is available for Patient Safety to satisfy AstraZeneca’s objectives in the Patient Safety area.
Ensure that own work and work of team is compliant with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
Use expertise and knowledge of global issues to develop strategic Physicians and Scientists objectives for inclusion into business objectives.
Provide TA Disease Area strategic PS input to a family of drug development and post-marketing programs across life-cycle of substances and products.
Be accountable at Portfolio-level for quality including review of key deliverables (eg RMPs and PSRs), and adherence to PV regulations.
Define strategies or leads AstraZeneca’s response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans.
Represent content matter expertise at high level decision-making bodies such as LSPC, SARB, ESB and Development Review Committee on behalf of the relevant PSTAVP.
Be responsible for SIRC Chair role and Chairperson consultation for assigned products.
Chair Patient Safety peer review.
Work across a number of disease areas in the TA and oversee Safety Physicians, Scientists and SSaMTs working in a portfolio of AstraZeneca assets in the TA.
Represent AstraZeneca Patient Safety in external regulatory meetings.
Influence AstraZeneca TA strategies.
Influence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organisation.
Review regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR).
Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans.
Follow important developments and trends in scientific literature and develops contacts with opinion leaders.
Share best practice in Patient Safety TA.
Participate in the respective PSTA leadership team.
Essential for the role:
Minimum PhD. Medical/clinical/scientific qualification and postgraduate training, or equivalent standards.
12 Years of relevant Pharma experience.
Experience in providing strategic leadership to complex drug projects.
Relevant industry experience in Pharmacovigilance field.
Experience in managing a scientific team.
Demonstrated ability to influence key stakeholders within and outside of company.
Demonstrated proficiency with both written and verbal communications.
Desirable for the role:
MD and or extensive experience in a scientific discipline.
Extensive general medical knowledge.
Able to work across TAs and Functions.
Research background including peer reviewed publications.
#J-18808-Ljbffr
Patient Safety at AstraZeneca is now looking for
Heads of Multiprogram Pharmacovigilance (PV) Oncology
to join our teams.
The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market.
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 offices are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
What you’ll do
The PV Head is a global role providing strategic PS input for TA and/or Disease Areas and quality and compliance oversight to a family of drug development and post-marketing programs across life-cycle of substances and products. This includes dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, risk management commitments, risk mitigation and communication.
The PV Head recruits and manages a global team of safety physicians and scientists, or recruit and manage a global team of group leaders and scientists and physicians, in order to support major PS programs and key initiatives.
Your main accountabilities / responsibilities:
Recruit and manage team of safety physicians and scientists supporting major programs, or recruit and manage team of group physician and scientist leaders.
Drive staff development in support of AstraZeneca products.
Contribute to ensure that an adequate number of qualified physicians and staff is available for Patient Safety to satisfy AstraZeneca’s objectives in the Patient Safety area.
Ensure that own work and work of team is compliant with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
Use expertise and knowledge of global issues to develop strategic Physicians and Scientists objectives for inclusion into business objectives.
Provide TA Disease Area strategic PS input to a family of drug development and post-marketing programs across life-cycle of substances and products.
Be accountable at Portfolio-level for quality including review of key deliverables (eg RMPs and PSRs), and adherence to PV regulations.
Define strategies or leads AstraZeneca’s response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans.
Represent content matter expertise at high level decision-making bodies such as LSPC, SARB, ESB and Development Review Committee on behalf of the relevant PSTAVP.
Be responsible for SIRC Chair role and Chairperson consultation for assigned products.
Chair Patient Safety peer review.
Work across a number of disease areas in the TA and oversee Safety Physicians, Scientists and SSaMTs working in a portfolio of AstraZeneca assets in the TA.
Represent AstraZeneca Patient Safety in external regulatory meetings.
Influence AstraZeneca TA strategies.
Influence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organisation.
Review regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR).
Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans.
Follow important developments and trends in scientific literature and develops contacts with opinion leaders.
Share best practice in Patient Safety TA.
Participate in the respective PSTA leadership team.
Essential for the role:
Minimum PhD. Medical/clinical/scientific qualification and postgraduate training, or equivalent standards.
12 Years of relevant Pharma experience.
Experience in providing strategic leadership to complex drug projects.
Relevant industry experience in Pharmacovigilance field.
Experience in managing a scientific team.
Demonstrated ability to influence key stakeholders within and outside of company.
Demonstrated proficiency with both written and verbal communications.
Desirable for the role:
MD and or extensive experience in a scientific discipline.
Extensive general medical knowledge.
Able to work across TAs and Functions.
Research background including peer reviewed publications.
#J-18808-Ljbffr