The Senior Director Patient Safety Scientist, Vaccines & Immune Therapies 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 PV.
The SD PS V&I recruits and leads a global team of PV physicians and scientists and leads strategic change projects across PS Therapeutic Areas.
If this sounds exciting to you, read on and apply as we can't wait to hear from you!
RESPONSIBILITIES 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, ensuring alignment with broader AstraZeneca goals and objectives.Development and retention of quality talent.Ensures alignment of work with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards, and all other relevant internal and external regulatory standards.Ensures 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, sharing this with team members as appropriate.Follows medical developments within assigned areas and disseminates new information within PS to transform trends and emerging data into new plans.Serves as SME for PV regulations and leads PS TA in regulatory agency inspections.Shares effective and efficient practices across Global PS teams (Therapeutic Areas, QPPV, Risk Management, Operations, and International).Leads PS activities into PV Agreements and serves as Lead for Managing Alliance Partners for assigned products.Provides expertise assuring best quality and results in: PV strategy, Safety Management, Vendor/Partner Management, and Periodic Reports including PBRERs, DSURs, etc.Partners with other parts of Global PS to implement changes in the PV legislative landscape to prepare appropriate resources and abilities to address the future.Leads or supports complex and pioneering projects to improve processes within PS or develop and introduce new technologies and approaches at the national, regional, or global level.Ensures 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 (e.g., 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
Master's degree or above or equivalent qualification in relevant scientific field.Experience leading a scientific team.Extensive proven experience in pharmaceutical or biotech industries within the Pharmacovigilance field.Knowledge of relevant legislation and developments within the 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 the company.Proficient in the 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.
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