AstraZeneca

Key Responsibilities

• • Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.
• • Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
• • Responsible for overall safety content for the product or indication(s) aligned to GPT strategy.
• • Sets safety team goals aligned to TA and product strategy.
• • Accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset for the assigned asset(s).
• • Accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
• • Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).
• • Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
• • Accountable for safety contribution to study designs and study concept delivery within their assigned program.
• • Provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).
• • Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset.
• • Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
• • Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team.
• • May be required to support in-licensing opportunities.
• • Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours.
• • Accountable for implementation of new processes, systems and learning, including new ways of working.
• • Prioritizes risk mitigation strategies and effective trouble shooting.
• • Line manages a team of safety physicians and / or scientists.
• • Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information.
• • Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally.
• • Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.
• • Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data.