Associate Director, Medical Safety Science - Acerta

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POST DATE 9/18/2016
END DATE 10/29/2016

AstraZeneca Pharmaceuticals LP Redwood City, CA

Redwood City, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Acerta Pharma was established in 2013 with a mission to discover and develop novel targeted molecules with the potential to improve patients' lives. At the core of our vision is a foundation based on cutting edge technologies, which enable the development of specific and selective drug candidates. Acerta's innovations translate to more effective and less toxic prospective therapies. As a member of the AstraZeneca group, Acerta is well positioned to rapidly achieve its first of hopefully several drug approvals to come. br br The Associate Director Medical Safety Science encompasses a key role in supporting the execution of departmental strategy and the day-to-day functioning of the Medical Safety group. This role may collaborate with colleagues and vendors representing Clinical Science, Clinical Operations, Safety Operations, Safety Excellence, Biometrics, Regulatory, QA, and Legal. br br Essential Duties/ Responsibilities: br br * Participates in the development and review of appropriate safety sections of key safety documents including: IBs, CSRs, protocols, ICF, RSI, CDS br * Participates in the preparation of DSURs, IND Annual Reports, PSURs/PBRERs, and other global periodic safety reports br * Supports execution of safety filing strategy as appropriate, including: ISS, SCS, CO, NDA, RMP, MAA, and product labels br * Supports the planning and preparation of the adverse events section of protocols and informed consents for clinical studies br * Participates in and supports management of medical review of individual case safety reports (ICSRs) for Acerta products throughout the life cycle, including review of SUSARs and IND Safety Reports, and including generation of Analysis of Similar Events as needed br * During medical review, supports Quality Control for of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database br * Liaises with other Medical Safety Science group members, and others as applicable, to ensure that appropriate medical review and assessment is provided for assigned case reports br * Liaises with Medical Monitors in Clinical Development as needed and provides appropriate medical review and assessment for assigned case reports Medical Review of SUSARs and CSR Narrative review, with follow up with site investigators as needed br * Ensures that the medical review workflow step for all safety reports received from any source are processed within timeframes that maintain compliance with ICH-GCP guidelines, regulatory requirements and company SOPs and procedures br * Participates in QA/QC of line-listings and aggregate summaries of applicable safety data br * Supports Benefit-Risk Assessment in collaboration with Clinical Science br * Supports the Signal and Risk Management for each product throughout the life cycle br * Signal Detection and Issue Workup: Supports identification and reporting on possible trends and concerns as they relate to Acerta-Pharma products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety br * May support activities for Investigator Sponsored Trials (ISTs), including review of protocols, informed consents, IST contracts, and appropriateness of safety data received from IST trials br * Supports the review and analysis of aggregate safety data from the clinical and/or safety database (e.g. in support of Data Monitoring Committee meetings, interim analyses, or final database lock) br * May participate in health authority interactions (both written and verbal) and inspections regarding safety and risk management br * Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems br * Supports the development of Medical Safety Science infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective br * Supports reconciliation activities, as applicable, to ensure high quality of safety data in the clinical and safety databases br * Compliant with departmental policies and SOPs applicable to Medical Safety Science that address medical/scientific aspects of reporting and processing of safety information, and analysis of safety data, to ensure proactive surveillance of products in development br * Compliant with training to company and department principles, policies and SOPs br * May also participate in other activities as required to support the day-to-day functioning of the Medical Safety Science group br br ~bsp br br