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Senior Director, Patient Safety Scientist, V&i
hace 2 semanas
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/scientifc 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 or scientists and leads strategic change projects across PS Therapeutic Areas.
**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, 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
- 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 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
- The annual base pay (or hourly rate of compensation) for this position ranges from _$211,343 to $317,014. _Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/te
