Executive Director Patient Safety Biopharma

hace 4 meses


Barcelona, España AstraZeneca A tiempo completo

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.

Patient Safety at AstraZeneca is now looking for an** Executive Director Major Program Patient Safety BioPharma **to join our team in **Gothenburg, Sweden.
**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.

**What you’ll do**

The Executive Director position 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.

In this position you will manage a global team of Global Safety Physicians and Strategic Safety Management Team Leaders, in order to support major PS programs and key initiatives.

**Your main accountabilities / responsibilities**:

- Drive staff development in support of AZ products
- 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 recruit and 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 - e.g to dTPPs, patient populations, scientific understanding of toxicity-related mechanisms, ensure risk management commitments, risk mitigation and communication.
- Be accountable at Portfolio-level for quality incl review of key deliverables (eg RMPsand 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 AZ assets in the TA
- Represent AZ PS in external regulatory meetings
- Influence AZ 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 and approve regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR, submission documents)
- 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 PS TA
- Participate in the PSTA BioPharma leadership team

**Essential for the role**
- Medical/clinical/scientific qualification and postgraduate training, or equivalent standards
- 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 partners within and outside of company
- Demonstrated proficiency with both written and verbal communications

**Desirable for the role**
- PhD in scientific field
- Extensive general medical knowledge
- Able to work across TAs and Functions
- Research background including peer reviewed publications

**Why AstraZeneca?**
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?

Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achiev



  • Barcelona, España Recruiting Erasmus A tiempo completo

    **AstraZeneca** is an innovation-driven global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, renal, and metabolic, respiratory, and immunological, oncological and rare diseases. In line with our firm commitment to training and developing...


  • Barcelona, España AstraZeneca A tiempo completo

    **Safety Physician - Patient Safety BioPharma** - 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 a** **Safety Physicians **to join our Patient Safety BioPharma team.** The positions...


  • Barcelona, España AstraZeneca A tiempo completo

    At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with...


  • Barcelona, España AstraZeneca A tiempo completo

    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. We do this with integrity even in the most difficult situations because we are committed to doing the right thing._ **Patient Safety Biopharma at AstraZeneca is now looking for a Director,...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location: Onsite 3 days/week in Barcelona** At AstraZeneca we turn ideas into life-changing medicines. Working here means being ambitious, thinking big and working together to make the impossible a reality. We do this with integrity even in the most difficult situations because we are committed to doing the right thing. **Patient Safety BioPharma at...


  • Barcelona, España Mymenopauserx, Llc A tiempo completo

    .This is what you will do:The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...


  • Barcelona, España AstraZeneca A tiempo completo

    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...


  • Barcelona, Barcelona, España Absoluteeldercare A tiempo completo

    Medical Director, Global Patient Safety | AbsoluteeldercareThis is what you will do:Key Responsibilities:Lead Risk Management Evaluation and Resolution: Utilize subject matter clinical and pharmacovigilance expertise to identify and evaluate safety signals and drive decision-making on risk/benefit evaluation and argumentation, pharmacoepidemiological or...


  • Barcelona, Barcelona, España Absoluteeldercare A tiempo completo

    Medical Director, Global Patient Safety | AbsoluteeldercareThis is what you will do:Key Responsibilities:Lead Risk Management Evaluation and Resolution: Utilize subject matter clinical and pharmacovigilance expertise to identify and evaluate safety signals and drive decision-making on risk/benefit evaluation and argumentation, pharmacoepidemiological or...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    .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.We do this with integrity even in the most difficult situations because we are committed to doing the right thing.Patient Safety at AstraZeneca is now looking for an experienced Senior...


  • Barcelona, España Astrazeneca A tiempo completo

    .The Associate Director, Patient Safety Device & Digital contributes to the Patient Safety Device, Digital and Diagnostic process area. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.The Associate Director, Patient Safety Processes & Partnerships responsibilities include but are not limited to providing...


  • Barcelona, España Astrazeneca A tiempo completo

    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...


  • Barcelona, España Astrazeneca A tiempo completo

    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...


  • Barcelona, España Astrazeneca A tiempo completo

    .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...


  • Barcelona, España Astrazeneca A tiempo completo

    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...


  • Barcelona, España Absoluteeldercare A tiempo completo

    Medical Director, Global Patient Safety | JJ-929This is what you will do: The Medical Director, Global Patient Safety is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare...


  • Barcelona, España Absoluteeldercare A tiempo completo

    Medical Director, Global Patient Safety | JJ-929 This is what you will do: The Medical Director, Global Patient Safety is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare...


  • Barcelona, España Astrazeneca A tiempo completo

    .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...


  • Barcelona, España Astrazeneca A tiempo completo

    .Medical Director, Patient Safety Physician Join us at AstraZeneca in the Vaccines and Immune Therapies division as a Medical Director, Patient Safety Physician. This role is pivotal in our mission to provide long-lasting immunity to millions of people and directly impact the lives of populations around the world. We are at an exciting frontier of medicine,...


  • Barcelona, España Absoluteeldercare A tiempo completo

    .This is what you will do:The Medical Director, Global Patient Safetyis accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The jobholder utilizes subject matter clinical...