Patient Safety Team Leader

AstraZeneca in Wilmington, DE

  • Industry: Healthcare - Allied Health - Others
  • Type: Full Time
position filled

Provides leadership and direction in area of expertise on pharmacovigilance activities as an expert or through the supervision of the section’s Business Support, Compliance Excellence, or Information Services team(s) on a variety of pharmacovigilance activities of multifaceted scope and complexity to both mitigate risk to the business and support our license to operate.Recognized as an expert in own field and often first point of contact for related queries.Provides analysis and trending of data and collaborates with stakeholders to identify trends through project management activities. Develops and maintains pharmacovigilance process and technology vision and strategy in support of the US region.

  • Ensures and monitors compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
  • Acts as a regional technical expert providing consultative guidance and support to internal groups and project teams for local processes ensuring compliance with global and local procedural documents and local implementation of pharmacovigilance objectives, policies, processes and procedures.
  • Serves as a technical knowledge expert with a deep understanding of internal, local and international regulatory requirements, regulations and guidance at the global and Regional level relevant to pharmacovigilance activities.
  • Provides guidance to internal groups and project teams based on technical knowledge towards development of strategic and tactical plans.
  • Leads and/or contributes to establishing and implementing policies, procedures and objectives for own work or though managing a team, to improve the quality, compliance and efficiency of deliverables for overall team efficiency based on good awareness of external competitive practice and required regulatory requirements.
  • Manages a wide range of problems independently, requiring complex judgments and innovative solutions, needing well-developed conceptual thinking and thus having a high level of business risk management.
  • Actively leads and provides guidance and support for regulatory inspection and audits.
  • Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and compliance.
  • Accountable for specialized research or delivery of internal reports to enhance the effectiveness of pharmacovigilance contributions to local and/or global submissions across a range of products.
  • Manages and authors applicable process procedural documents, guidance documents or system specification documents.
  • Leads the monitoring of compliance with safety-related regulations, corporate policies, SOP’s and guidelines through internal audits, quality control and training.
  • Ensures that regional input is provided in determining requirements for new/updated processes and procedures in support of internal, local and international regulatory requirements.
  • Collaborates with line management on resource activities to insure appropriate prioritization of resources to deliver key work and provides feedback to ensure the right skills and expertise are deployed to the team to enable achievement of its objectives.
  • Implements continuous improvement plans around departmental compliance of local and global guidelines, working instructions, SOPS and Corporate policies.
  • Develops innovative strategies to meet Patient Safety’s training needs.
  • Provides leadership around project management activities in US Patient Safety.
  • Liaises with internal and external stakeholders as necessary for issue and resolution activities.
  • Demonstrates the ability to present information to both internal and external stakeholders.
  • Conducts training in both classroom and individualized settings.
  • Provides support, guidance and training to internal staff.
  • Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
  • Supports a performance-driven culture within the teams with visible performance metrics and visible recognition and rewards.
  • Essential Requirements

  • Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background with proven competence in Patient Safety/Clinical Development.
  • 8-10 years of pharmacovigilance and/or Clinical Development experience with a minimum of 5 years of pharmacovigilance department experience to include knowledge of pharmacovigilance practices, including an advanced understanding of FDA and other Health Authority, and ICH regulatory requirements, guidance and obligations.
  • Delivery focused.
  • Proven leadership and professional skills, able to resolve conflict.
  • Strategic thinking.
  • Demonstrated ability to work with a high degree of autonomy.
  • Demonstrated ability to work effectively as a member of a cross-functional or global team with ability to work across cultures.
  • Demonstrated ability to represent the organization externally where required.
  • Demonstrated ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas.
  • Proven professional excellence – adds value by applying expertise proactively.
  • Demonstrated ability to influence whilst maintaining independent and objective views.
  • Maintains high ethical standards, including a commitment to AstraZeneca values and behaviors.
  • Excellent communication and organizational skills.
  • Detail oriented.
  • Computer literate.
  • Desirable

  • Advanced degree within field and/or professional certification (project management, Lean Six Sigma, ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/ Organizational Excellence, or SQA Registered Quality Assurance Professional (Minimum 3 years of PV-related Quality Assurance auditing experience).
  • Strong pharmacovigilance experience within the pharmaceutical industry and prior pharmacovigilance case handling or compliance, audit/regulatory inspection or IS/IT experience in a Patient Safety department.
  • Strong project management expertise.
  • Proven courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others to accomplish individual, team and organizational objectives.
  • Professional excellence: Background of high professional achievement and willingness to encourage this in others.
  • Creative and Innovative: Seeks to improve continuously where it counts, based on good awareness of external competitive practice, and creativity and initiative.
  • Demonstrated ability to develop others, identifying and providing opportunities to improve the capabilities of other people.
  • Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.
  • AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.


    You may be interested in these similar jobs!
    Director of Tour Operations
    Aardvark Event Logistics in Conshohocken, PA

    At Aardvark Event Logistics, our strength is the efficiency with which we deliver unrivaled Experiential Marketing Mobile Tours. We’re proud to set t…

    Read More
    Structural Project Designer
    MacIntosh Engineering in PA

    Summary: Works with project managers to prepare and develop structural designs of structural framing and foundation systems of various commercial, in…

    Read More
    Environmental Services / Custodial Manager 2
    Sodexo in Philadelphia, PA

    Use your best in class housekeeping/custodial management skills to make a real impact on patient healing. Sodexo is seeking an Environmental Services…

    Read More
    Environmental Services / Custodial Manager
    Sodexo in Philadelphia, PA

    Use your best in class housekeeping/custodial management skills to make a real impact on patient healing. Sodexo is seeking an Environmental Services…

    Read More
    Nurse Manager
    Main Line Health in Wynnewood, PA

    Description : Could you be our next Nurse Manager of our PACU and Pre-Admission Testing areas? Lankenau Medical Center , a 331-bed not-for…

    Read More
    Charge nurse med/surg houston methodist the woodlands hospital
    Houston Methodist Hospital in Spring City, PA

    Job Description Work Shift: DAY Work Week: M F Job Summary JOB SUMMARY At Houston Methodist, the Charge Nurse position is a licensed professional Reg…

    Read More
    Assistant Team Manager, Wound Care RN, Penn Medicine at Home
    Penn Medicine in Bala Cynwyd, PA

    Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educati…

    Read More
    Clinical Project Leader - Work from home
    PRA Health Sciences in Philadelphia, PA

    The primary role of the Clinical Project Leader (CPL), is to act as the key operational interface with internal and external services to develop, imp…

    Read More
    Sr Clinical Data Coordinator RN (CCCEO) - 62035
    Chop in Philadelphia, PA

    LOC_MAIN-Main Hospital Req ID: 55121Shift: DaysEmployment Status: Regular - Full Time Job SummaryResponsible for the conduct and direction of clinica…

    Read More
    Nuclear Medicine Technologist (PRN)
    Aspen Valley Hospital in New Castle, DE

    Under general supervision of the Manager and Chief Technologist, this position is responsible for providing Nuclear Medicine Images of technical deta…

    Read More
    Restaurant Team Leader
    Goodwin Recruiting in Malvern, PA

    Restaurant Team Leader opportunity. We are looking for a great FOH Leader to come be part of our ever-growing team of professionals. If you are looki…

    Read More
    Outpatient Registered Nurse - RN
    Acumen Physician Solutions in Narberth, PA

    PURPOSE AND SCOPE: The registered professional nurse (CAP RN 1) position is an entry level designation into the Clinical Advancement Program fo…

    Read More