Manager, Aggregate Safety/PV Technical Scheduling Lead (Caldwell)

  • Caldwell, NJ

Employment Type

: Full-Time

Industry

: Non-Executive Management



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ROLE SUMMARY

Pfizer is excited to present an Aggregate Report Management Scheduling Lead open position. In this role you will have the opportunity to oversee all aspects of creating, maintaining and implementing a comprehensive, dynamic and resource efficient calendar of safety aggregate report deliverables.This includes, but is not limited to IND ARs, DSURs, PADERs, PAERs, PSURs and SUSAR LLs.This position also negotiates safety submission commitments with Pfizer Country Offices and/or Regulatory, ensuring compliance needs are met while balancing resource effort to create submission documents; interacting with requestors to resolve ad hoc report scheduling, and propose the assignments.

ROLE RESPONSIBILITIES

  • Create and maintain the comprehensive safety aggregate report calendar, including entering and assigning the deliverables.
  • Design, implement, and report relevant aggregate reporting metrics.
  • Acts as a business subject matter expert for systems used for aggregate reports calendar and participates in various technology forums.
  • Negotiate with appropriate groups to ensure that aggregate report commitments are met, while minimizing, the number of individual reports required, when possible, as well as developing schedules for new aggregate report types as required by regulations. Is empowered to make decisions.
  • Acts as a subject matter expert on aggregate reports scheduling and represents this role on various teams and task forces.
  • Supports Audit/inspection requests.
  • Ability to manage projects including aggregate report mailboxes.
  • BASIC QUALIFICATIONS

  • Bachelors degree required
  • Technical/IT background with 5 years experience in the pharmaceutical industry, regulatory agency, or related field.
  • Comprehensive working knowledge and understanding of IT requirement gathering, database structure, design and reporting tools
  • Demonstrated ability to lead/manage and bring projects to successful completion while simultaneously juggling multiple projects and processes that span globally.
  • PREFERRED QUALIFICATIONS

  • Knowledge/understanding of technologies that can support Pfizers safety submission work (e.g. Business Intelligence/Business Objects, Pegasystems) and ability to adequately evaluate and leverage Pfizers system into improved business processes to support business requirements.
  • Comprehensive knowledge of the regulatory environment
  • Experience supporting safety audits/Inspections
  • Strong interpersonal skills with demonstrated ability to build relationships and influence outcomes.
  • Sunshine Act

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Other Job Details:

  • Additional Location Information: Can be based out of any US Pfizer site or be remote based
  • Eligible for Employee Referral Bonus
  • #LI-PFE

    N (Other) (United States of America)

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.




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