PVA Informatics, Quality and Support Senior Manager - Collegeville, PA | Biospace
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PVA Informatics, Quality and Support Senior Manager

Pfizer Inc.

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Location:
Collegeville, PA
Posted Date:
8/23/2017
Position Type:
Full time
Job Code:
1605974
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

* Leads / co-leads or supports projects for PV Licensing colleagues supporting WSR.
* In collaboration with leadership of PSPS impacted functional lines, drive and implement relevant planning, execution, and governance strategies associated with PV Licensing projects.

* Responsible for alignment with Business Development and BU/RU goals as it relates to the overall delivery of quality PV Licensing projects deliverables.

* May lead / co-lead one or more strategic PV Licensing improvement activities for continuous system development and improvement.

* Oversees monitoring and exchange of PVA deliverables, inclusive of :
o PharmacoVigilance eXchnage (PvX) system configuration, enhancement, and maintenance
o Quality and performance metrics for the team, in conjunction with other WWS functions within the Quality System.
o Quality review of data entry into PvX

o Generation of reports and data mining in support of regulatory inspections, internal and partner audits, queries, and internal needs
o Interaction and involvement in communication with PVA alliance partners, under the guidance and oversight of the PVA Licensing Lead.Partnering relationships to mentor/coach Technical Coordinator

Requirements

A scientific or technical degree is preferred. Master's degree is desirable. In general, candidates for this job would have the following levels of education/experience:

* Bachelor's degree and relevant 5-7 years industry experience, and total of 10 years work experience.

* Previous experience within, or close interaction with, Safety and/or Regulatory functions within a pharmaceutical company or Clinical development functions in order to have a thorough understanding of operational requirements.

* Experience in contract or alliance management preferred, but not essential

* Experience in process review, management and change management within global systems.

* Knowledge and understanding of project resource needs, ability to translate project requirements into effective solutions.

* Excellent analytical and strategic thinking skills.

* Demonstrated effective influencing and negotiating, interpersonal, leadership, and team player skills.

* Excellent presentation and communication skills.

* The Informatics, Quality & Support Senior Manager will be responsible for managing PV Licensing projects. The incumbent will be responsible for supporting both novel and routine PV Licensing processes, within and across PSPS, under the oversight of the respective PVA Licensing Lead, PV licensing or PSPS management. Informatics, Quality & Support Senior Manager coaches and mentors technical support team member(s). The Informatics, Quality & Support Senior Manager monitors and quality manages processes, compliance, and performance metrics and provides appropriate outputs to the Pfizer quality committees and to line management.

* Leads/Co-leads projects; develops and manages plans to achieve objectives.

* Develop innovative and original ideas to set tactical approaches and drive more effective, operational plans for delivery of PV Licensing projects. Has advanced knowledge, serves as advisor as appropriate for PV strategies developed with Business Units in regards to technical interface and data exchange.

* Promote awareness and understanding of relevant PV Licensing processes and deliverables to ensure effective collaboration and critical inputs with key internal/external interfaces (Regulatory, Business Development, Legal, BU/RU, Contractual Partner, etc).

* Applies technical and functional line knowledge to plan/design projects that will enable meeting PV Licensing objectives.

* Makes decisions that require developing innovative options to resolve complex problems. Operates independently in ambiguous situations.

* Uses a variety of communication tools and techniques to develop, refine, and apply critical success factors with relevant functional lines to support Contractual Partner relationships including: metrics management, governance, communication pathways, issue resolution/escalation.

* Build strong relationships with relevant functional lines and stakeholders across Pfizer to drive collaborative partnership with PV Licensing team.

* Exercises foresight and judgment utilizing comprehensive breadth of knowledge and prior work experience to identify new continuous improvement opportunities and drive implementation of enhanced PV Licensing strategies.

* Responsible for quality of own PV Licensing work product and technical support team member(s).

* Acts as technical resource for others. Works independently on most assignments using knowledge and work experience to achieve desired results.

* Actively mentors and coaches colleagues as appropriate.

* Actively participates in periodic operational staff meetings to share best practice, continuous improvement, to pro-actively address issues, to ensure staff are compliant with processes, templates and training; frequently initiates topics and solutions.

* May lead / co-lead creation or revision of relevant PV Licensing procedural documentation or standardised template forms.

  • Last Date to Apply for Job: August 20, 2017
  • Grade: 11

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.

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 provider's 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.