Senior Director, Patient Safety Physician V&I

Join our Patient Safety team!

Job Title: Senior Director, Patient Safety Physician, V&I

Location: Onsite 3 days in Gaithersburg MD OR Mississauga CAN OR Barcelona SPAIN

ABOUT ASTRAZENECA

At AstraZeneca, our values-based culture contributes to a desirable working environment, a purposeful mission of putting patients first who benefit from following the science, doing the right thing and a confident entrepreneurial spirit. We are looking for people who have expertise and passion for PS. Would you like to apply your expertise to provide scientific and clinical strategic leadership in a company that espouses these values and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

JOB CAPSULE DESCRIPTION

The Senior Director, Patient Safety Physician V&I is a global role ensuring oversight of Safety Physician and SSaMT input to programs and delivery. This role provides the strategic medical/scientific leadership for assigned programs and the expertise to ensure quality results for Pharmacovigilance. The SD PS V&I Physician recruits and leads a global team of PV physicians and or scientists and leads strategic change projects across PS Therapeutic Areas.

TYPICAL ACCOUNTABILITIES

• Recruits and leads a team of safety scientists and staff; provides strategic leadership for assigned TA programs. Additionally, will lead strategic change initiatives across global PS

• Develops objectives for PS in TA area of responsibility, and ensures these are aligned to broader AstraZeneca goals and objectives.

• Development and retention of quality talent.

• Ensures that own work and work of team is aligned with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulatory standards.

• Ensure oversight of SSaMT input to programs and delivery of outputs.

• Maintains a high degree of understanding and awareness of scientific developments which could potentially impact PS and the broader AZ organization, and shares this with team members as appropriate.

• Closely follows medical developments within assigned areas and disseminates new information within PS to transform trends and emerging data into new plans.

• Serve as SME for PV regulations and leads PS TA in regulatory agency inspections.

• Sharing effective & efficient practices across Global PS teams (Therapeutic Areas, QPPV, Risk Management, Operations and International)

• Lead PS activities into PV Agreements and serves as Lead for Managing Alliance Partners for assigned products

• Provide expertise assuring best quality and results in: PV strategy, Safety Management, Vendor/Partner Management, and Periodic Reports including PBRERs, DSURs, etc.

• Partner with other parts of Global PS to implement changes in PV legislative landscape to prepare appropriate resources and abilities to address the future

• Lead or support complex and pioneering projects to improve processes within PS or develop and introduce new technologies and approaches at the national, regional or global level

• Ensure full implementation of all PS, TA and broader AZ enterprise global strategic change programs

• Builds networks within Global PS and external partners to learn about new developments, leverage opportunities and share efficient and effective practices (eg Benchmarking and Industry forums)

• Expected to Deputize for PS TA lead and actively participate in PS TA Leadership Team

EDUCATION, QUALIFICATIONS, SKILLS AND EXPERIENCE

Essential

• MD degree or equivalent international diploma in relevant medical field

• Experience leading a scientific team of physicians

• Extensive proven experience in pharmaceutical or biotech industries within Pharmacovigilance field

• Knowledge of relevant legislation and developments within industry

• Experience in either writing risk management plans and assessing risk mitigation activities or in translating preclinical safety experience to FIM trials

• Experience in leading sophisticated strategic projects (Drug and non-drug)

• Demonstrated capability to influence key partners within and outside of company

• Proficient in English language in both written and verbal communications

• Proven skills at providing strategic contributions into strategic decision making

Desirable

• Excellent reputation within the business and industry

• Extensive knowledge of the latest technical and regulatory expectations

EMPLOYER OF CHOICE

At AstraZeneca we are dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and ignite your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society because AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

We offer an industry wide generous Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a benefits package to include medical, dental, vision care, 401K among other offerings.

AstraZeneca aligns with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

11-Jun-2024

Closing Date

11-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.