Patient Safety Compliance Management Associate/Sr Associate
Posted on: December 5, 2018
At AstraZeneca we believe in the potential of our people and we'll develop you beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a US Patient Safety Compliance Management Associate/Senior Associate in Wilmington, DE, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. As a member of the US Patient Safety Compliance Management Team, you will prepare lifecycle management of pharmacovigilance processes and adhere to local regulatory guidelines. You will initiate, investigate and provide root cause and corrective and preventative actions to investigations. Additionally, you will supportmonthly quality checks, vendor compliance and contribute data to the Patient Safety Monthly Dashboard. This position carries out a range of activities and processes to provide support to the US Medical Affairs Patient Safety business unit that are both routine and very specific depending on the query. This role impacts the reputation of the function it serves as the initial point of contact for many customers. Typical Accountabilities:* Conducts activities and interactions consistent with company values and in compliance with the Code of Conduct and supporting policies and standards relevant to the role. Completes all required training on AstraZeneca's Code of Conduct and supporting policies and standards on time. Reports potential issues of non???compliance.* Demonstrates a working knowledge and compliance with organizational global and local procedural documents and local implementation of objectives, policies, processes and procedures and regulatory requirements, guidelines and obligations relevant to pharmacovigilance activities and adverse event reporting, including periodic safety reporting.* Coordinates the collection of reasons for late adverse event reporting, conducts root cause analysis, corrective actions to prevent future late reporting, and trending analyses from clinical, regulatory and marketing and any other internal/external customers for inclusion in safety reports to regulatory agencies within established timelines.* Contributes to the development, improvement and validation of procedures, policies, processes, guidelines and/or systems for the pharmacovigilance components of various activities and ensures they are compliant with organizational standards and ensures non???compliant processes are escalated.* Contributes to the pharmacovigilance components of contracts/agreements with third parties to ensure quality and integrity of agreement.* Maintains well???documented files for training records, processes reviews and investigations, etc. to meet internal and external requirements.* Produces accurate and fit for purpose safety data output for submission to internal and/or external sources.* Continuously builds upon own knowledge of best practices and new relevant developments current by learning from more senior colleagues.* Effectively coordinates, manages and delivers multiple assignments with competing timelines.* Participates in cross???functional project team meetings to provide pharmacovigilance guidance to contributors of documents for submission to regulatory agencies.* Maintains local internal compliance and external reporting schedules.* Supports regulatory inspections and internal audits.* Demonstrates the ability to present information to both internal and external stakeholders.* Conducts training in both classroom and individualized settings.* Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.* Supports a performance???driven culture. Senior Associate will in addition:* Provides training and mentoring of Patient Safety staff on local and global compliance reporting, project work and with respect to career development* Demonstrates leadership ability by conducting team meetings independently and managing special projects* Have effective project???management skills, including the ability to manage multiple competing tasks* Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues* Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers* Supports Safety Surveillance, Safety Support - Compliance Management and Marketing Company and US Medical Affairs and the US Clinical Teams* Serves as a knowledge resource for departmental personnel regarding medical, scientific and* Operational issues* Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries, collection of safety data and FDA / AZ processes and regulations* Contribute to the implementation of new safety???related systems, processes and procedures within the region* Participates in cross???functional project team meetings to provide guidance to contributors of documents for submission to regulatory authorities Essential Requirements:* Highschool diploma* 1???2years'experienceinthepharmaceutical industry,withknowledgeofpharmacovigilance practices,includingabasicunderstandingofFDA andotherHealthAuthority,andICHregulatory requirements,guidanceandobligations * Basiccompetencewithmedicalandtherapeutic terminology * Demonstratedsuccessworkingeffectivelyina cross???functionalteamenvironmentwithabilityto workacrosscultures * Demonstratedsuccessworkingindependently, guidedbyprocedures,withappropriatesupport * FluentinEnglishlanguagewithexcellent communicationskills,bothoralandwritten * Demonstratedsuccessinmanagingmultiple competingassignmentsandtimelines * Demonstratesabilitytomaintainhighethical standards,includingacommitmentto organizationvaluesandbehaviors * Detailoriented * Computerliterate Desirable:* Bachelor'sDegree * Experiencewithinthepharmaceuticalindustry andpriorpharmacovigilancecasehandlingor pharmacovigilance complianceexperienceina PatientSafetydepartment * Projectmanagementexpertise AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Keywords: AstraZeneca, Wilmington , Patient Safety Compliance Management Associate/Sr Associate, Executive , Wilmington, North Carolina
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