Pharmacovigilance (PV) Medical Director - Onc

AstraZeneca - Gaithersburg, MD - 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 Pharmacovigilance (PV) Medical Director Patient Safety Oncology to join our teams in Gaithersburg, US 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 PV Medical Director is a global role ensuring oversight of Safety Physician and SSaMT input to programs and delivery of safety outputs. This role provides strategic medical/scientific safety leadership for assigned programs and expertise to assure quality deliverables for PV. The PV Medical Director recruits and manages a global team of safety physicians and leads strategic change projects across PS TAs. Your main accountabilities / responsibilities: In the role as the PV Medical Director, Patient Safety Oncology, you will: Recruit and manage team of safety physicians Develop objectives for Patient Safety in area of responsibility, and ensures these are aligned to broader AstraZeneca goals and objectives. Recruit, develop and retention of talent. 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 Ensure oversight of Safety Physician and SSaMT input to programs and delivery of outputs in partnership with PV Heads and/or PV Science Director Provide strategic medical/scientific safety leadership for assigned programs Maintain a high degree of understanding and awareness of internal and external developments that could affect Patient Safety and the AZ R&D Units , and shares this with team members as appropriate Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans Share best practice across teams in PSTA and between PSTAs, partner with PS CoE. Provide expertise assure quality deliverables for PV (Safety Handling Plan, PSSR, SSaMT plan) and Periodic Reports including PBRERs, DSURs, etc. in partnership with PV Heads and/or PV Science Director Lead strategic change projects across PS TAs May manage or support complex and cutting edge projects to improve processes within Patient Safety or develop and introduce new technologies and approaches at the national, regional or global level Ensure full implementation of all Patient Safety and R&D strategic change programs Build networks with other PS TAs/teams and external stakeholders to learn about new developments, leverage opportunities and share best practices (eg Benchmarking and Industry forums) Can deputize for PV Head Participate in the respective PSTA leadership team Essential for the role Degree in medicine MD, MBBS etc. and experience as a physician or academic Experience in managing a scientific team. Extensive industry experience in Pharmacovigilance field Knowledge of relevant legislation and developments in the Pharmaceutical industry Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to man Experience in leading complex strategic projects (Drug and non-drug) Demonstrated ability to influence key stakeholders within and outside of company Demonstrated proficiency with both written and verbal communications Desirable for the role PhD in relevant scientific discipline Expert reputation within the business and industry Extensive knowledge of the latest technical and regulatory expectations So, what's next? If you are interested, we have a seat waiting for apply we are vitually hiring during he Covid Pandemic... - Permanent - Full-time

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