Senior Director, Patient Safety Physician V&I

5 months ago

Mississauga, Canada AstraZeneca Full time
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

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